{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "LITTLE REMEDIES NEW BABY ESSENTIALS ACETAMINOPHEN, SIMETHICONE, ZINC OXIDE LITTLE REMEDIES INFANT FEVER and PAIN RELIEVER ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN BENZOIC ACID CARBOXYMETHYLCELLULOSE GLYCERIN MICROCRYSTALLINE CELLULOSE SUCROSE SODIUM BENZOATE WATER XANTHAN GUM LITTLE REMEDIES RELIEF SIMETHICONE DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM CITRIC ACID MONOHYDRATE MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE XANTHAN GUM BOUDREAUXS ZINC OXIDE ZINC OXIDE ZINC OXIDE CASTOR OIL MINERAL OIL PARAFFIN BALSAM PERU PETROLATUM beige Gripe Water Ginger and Fennel GINGER GINGER FENNEL FENNEL WATER AGAVE TEQUILANA JUICE GLYCERIN CITRIC ACID MONOHYDRATE POTASSIUM SORBATE XANTHAN GUM clear Saline WATER SODIUM CHLORIDE GLYCERIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POTASSIUM PHOSPHATE, UNSPECIFIED FORM BENZALKONIUM CHLORIDE EDETATE DISODIUM" ], "spl_unclassified_section": [ "FOR FEVERS TM INFANT FEVER + PAIN RELIEVER Acetaminophen Drug Facts", "Other ingredients purified water, agave, glycerin, natural ginger flavor, potassium sorbate, citric acid, xanthan gum Suggested Use Age Dose 2 to 4 weeks 2.5 mL 1 to 6 months 5 mL 6 months and older 10 mL Adults 30 mL SHAKE WELL . May be taken directly using the dispenser included. May be given up to six times in a 24 hour period. If necessary to repeat dosage, wait a minimum of 30 minutes. Do not use if safety seal is broken or missing. Keep out of reach of children. In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage. Do not use if ▪ child has a history of kidney failure or renal problems ▪ child is allergic to any of the ingredients in this product Always consult your health care provider before giving this or any supplement to an infant. ▪ Store at room temperature. FOR NOSES TM SALINE SPRAY + DROPS" ], "active_ingredient": [ "Active ingredient (in each 5 mL) Acetaminophen 160 mg", "Active ingredient (in each 0.3 mL) Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg" ], "purpose": [ "Purpose Pain reliever / Fever reducer", "Purpose Antigas" ], "indications_and_usage": [ "Uses Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.", "Uses Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food", "Uses –Helps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. For infants this can be assisted with the use of our specially designed “Soft Tip” Nasal Aspirator." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ▪ more than 5 doses in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other products containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doc tor before use if the child has liver disease. Ask a doctor or pharma cist before use if the child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. These could be signs of a serious condition. Keep out of reach of children. Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.", "Warnings Keep out of reach of children.", "Warnings Keep out of reach of children. ▪ The use of this dispenser by more than one person may spread infection. ▪ Wipe nozzle clean after each use." ], "do_not_use": [ "Do not use with any other products containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product.", "Do not use if ▪ child has a history of kidney failure or renal problems ▪ child is allergic to any of the ingredients in this product Always consult your health care provider before giving this or any supplement to an infant. ▪ Store at room temperature. FOR NOSES TM SALINE SPRAY + DROPS" ], "ask_doctor": [ "Ask a doc tor before use if the child has liver disease." ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharma cist before use if the child is taking the blood thinning drug warfarin." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. These could be signs of a serious condition." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.", "Keep out of reach of children.", "Keep out of reach of children. In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.", "Keep out of reach of children. ▪ The use of this dispenser by more than one person may spread infection. ▪ Wipe nozzle clean after each use." ], "dosage_and_administration": [ "Directions This product does not contain directions or complete warnings for adult use. Shake well before using Find the right dose on the chart on the chart below. If possible, use weight to determine dose; otherwise, use age. Only use the enclosed AccuSafe® syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. Remove cap, insert syringe to flow restrictor and invert bottle Pull back syringe until filled to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek) If needed, repeat dose every 4 hours while symptoms last Do not give more than 5 times in any 24-hour period (see overdose warning) Do not give more than 5 days unless directed by a doctor Replace cap tightly to maintain child resistance mL = milliliter Weight (lbs) Age (yrs) Dose (mL) Under 24 under 2 Ask a doctor 24-35 2-3 5 mL", "Directions ■ shake well before using ■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek ■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day. ■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids ■ for best results, clean syringe after each use and replace original cap If possible, use weight to determine dose; otherwise use age. mL = milliliters Age (yrs) Weight (lbs) Dose Newborns & Infants under 2 years under 24 0.3 mL Children 2 years and over 24 and over 0.6 mL", "Directions (For nasal use only) ▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor. ▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor. Store at 20°-25°C (68°-77°F). See bottle for lot and expiration date." ], "dosage_and_administration_table": [ "
Weight (lbs)Age (yrs)Dose (mL)
Under 24under 2Ask a doctor
24-352-35 mL
", "
Age (yrs)Weight (lbs)Dose
Newborns & Infants under 2 yearsunder 240.3 mL
Children 2 years and over24 and over0.6 mL
" ], "other_safety_information": [ "Other information Store at 20°-25°C (68°-77°F) AccuSafe® Oral dosing device enclosed Check expiration date on bottle or box before using.", "Other information ■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F) ■ See bottle or box for lot number and expiration date" ], "inactive_ingredient": [ "Inactive ingredients benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum FOR DIAPER RASH BOUDREAUX’S BUTT PASTE ® Diaper Rash Ointment Drug Facts Active ingredient Purpose Zinc oxide, 16%...................................................Skin protectant Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness Warnings For external use only When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve after 7 days Keep out of the reach of children to prevent accidental ingestion If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately Directions Change wet and soiled diaper immediately Cleanse the diaper area and allow to dry Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime Other i nformation Store at room temperature 20°- 27°C (68°- 80°F) Remove seal from jar before use Use with infants, children and adults Will stain clothing and fabric Inactive ingredients castor oil, mineral oil, paraffin, peruvian balsam, white petrolatum Questions ? 1-855-785-2888 www.buttpaste.com FOR TUMMYS TM GAS RELIEF DROPS Simethicone / Antigas Drug Facts", "Inactive ingredients carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum FOR TUMMYS TM GRIPE WATER Supplement Facts Serving Size: 5 mL Servings per Container: about 12 Amount per Serving % Daily Value Zingiber officinale (Ginger) Root Extract 5 mg † Foeniculum vulgare (Fennel) Seed Extract 4mg † †Daily Value not established", "Ing r edients : water, sodium chloride, glycerin, sodium benzoate, benzoic acid" ], "inactive_ingredient_table": [ "
Drug Facts
Active ingredient Purpose
Zinc oxide, 16%...................................................Skin protectant
Uses
Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only
When using this product avoid contact with the eyes
Stop use and ask a doctor if condition worsens or does not improve after 7 days
Keep out of the reach of children to prevent accidental ingestion
If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately
Directions
Change wet and soiled diaper immediately
Cleanse the diaper area and allow to dry
Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
Other information
Store at room temperature 20°- 27°C (68°- 80°F) Remove seal from jar before use
Use with infants, children and adults
Will stain clothing and fabric
Inactive ingredients castor oil, mineral oil, paraffin, peruvian balsam, white petrolatum
Questions?
1-855-785-2888 www.buttpaste.com
", "
Supplement Facts Serving Size: 5 mL Servings per Container: about 12
Amount per Serving% Daily Value
Zingiber officinale (Ginger) Root Extract 5 mg †
Foeniculum vulgare (Fennel) Seed Extract 4mg†
†Daily Value not established
" ], "spl_unclassified_section_table": [ "
Suggested Use
AgeDose
2 to 4 weeks2.5 mL
1 to 6 months5 mL
6 months and older10 mL
Adults30 mL
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Little Remedies® New Baby Essentials Kit INFANT FEVER/PAIN RELIEVER ACETAMINOPHEN / FEVER/PAIN RELIEVER 2 FL OZ (59 mL) Syringe Included GAS DROPS SIMETHICONE /ANTIGAS 1 FL OZ (30 mL) Syringe Included DIAPER RASH OINTMENT ZINC OXIDE / SKIN PROTECTANT 2 OZ (57 g) SALINE SPRAY + DROPS 0.5 FL OZ (15 mL) GRIPE WATER GINGER / FENNEL SUPPLEMENT 2 FL OZ (59 mL) Syringe Included Nasal Aspirator PRINCIPAL DISPLAY PANEL Little Remedies® New Baby Essentials Kit INFANT FEVER/PAIN RELIEVER ACETAMINOPHEN / FEVER/PAIN RELIEVER 2 FL OZ (59 mL) Syringe Included GAS DROPS SIMETHICONE /ANTIGAS 1 FL OZ (30 mL) Syringe Included DIAPER RASH OINTMENT ZINC OXIDE / SKIN PROTECTANT 2 OZ (57 g) SALINE SPRAY + DROPS 0.5 FL OZ (15 mL) GRIPE WATER GINGER / FENNEL SUPPLEMENT 2 FL OZ (59 mL) Syringe Included Nasal Aspirator" ], "set_id": "4b1b7294-aca6-45fa-a008-c1869131b2a3", "id": "e64d548a-a9e1-430b-9091-628e8db105dc", "effective_time": "20241206", "version": "2", "openfda": { "brand_name": [ "LITTLE REMEDIES NEW BABY ESSENTIALS" ], "generic_name": [ "ACETAMINOPHEN, SIMETHICONE, ZINC OXIDE" ], "manufacturer_name": [ "Medtech Products Inc." ], "product_ndc": [ "63029-615" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "198857", "307675" ], "spl_id": [ "e64d548a-a9e1-430b-9091-628e8db105dc" ], "spl_set_id": [ "4b1b7294-aca6-45fa-a008-c1869131b2a3" ], "package_ndc": [ "63029-615-01" ], "is_original_packager": [ true ] } } ] }