{
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"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": "2026-06-02",
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{
"spl_product_data_elements": [
"CVS childrens Cough and Cold chlorpheniramine maleate, dextrometrorphan HBr ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN LACTIC ACID, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN"
],
"spl_unclassified_section": [
"DRUG FACTS"
],
"active_ingredient": [
"ACTIVE INGREDIENTS (in each 10 mL) Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 mg"
],
"purpose": [
"PURPOSES Antihistamine Cough suppressant Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat"
],
"indications_and_usage": [
"Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat"
],
"warnings": [
"WARNINGS Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Directions measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 4 doses in any 24-hour period age dose Children under 6 years do not use children 6 to under 12 years 10 mL every 6 hours adults and children 12 years and older 20 mL every 6 hours Other information each 10 mL contains: sodium 7 mg store at room temperature, Do not refrigerate."
],
"warnings_table": [
"
age
dose
Children under 6 years
do not use
children 6 to under 12 years
10 mL every 6 hours
adults and children 12 years and older
20 mL every 6 hours
"
],
"do_not_use": [
"Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."
],
"ask_doctor": [
"Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema"
],
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"
],
"when_using": [
"When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"
],
"stop_use": [
"Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding, ask a health professional before use."
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222."
],
"dosage_and_administration": [
"Directions measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 4 doses in any 24-hour period age dose Children under 6 years do not use children 6 to under 12 years 10 mL every 6 hours adults and children 12 years and older 20 mL every 6 hours Other information each 10 mL contains: sodium 7 mg store at room temperature, Do not refrigerate."
],
"dosage_and_administration_table": [
"
age
dose
Children under 6 years
do not use
children 6 to under 12 years
10 mL every 6 hours
adults and children 12 years and older
20 mL every 6 hours
"
],
"other_safety_information": [
"Other information each 10 mL contains: sodium 7 mg store at room temperature, Do not refrigerate."
],
"inactive_ingredient": [
"Inactive ingredients citric acid, FD&C red no. 40, Glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose"
],
"questions": [
"QUESTIONS OR COMMENTS? 1-866-467-2748"
],
"package_label_principal_display_panel": [
"PRODUCT PACKAGING Compare to the active ingredients in Children’s Robitussin ® Cough & Cold Long–Acting* NDC 51316-745-04 Children’s COUGH & COLD Chlorpheniramine Maleate USP 2 mg (Antihistamine) Dextromethorphan HBr, USP 15 mg (Cough Suppressant) Long-Acting Relieves: Cough up to 8 hours Runny nose For Ages 6 & Over Fruit Punch Flavor Naturally and Artificially Flavored 4 FL OZ (118 mL) IMPORTANT: Keep this carton for future reference on full labeling Distributed by: CVS childrens Cough & Cold 4 FL OZ Fruit Punch Flavor"
],
"set_id": "035c5e2a-04e3-490b-8f1a-233a5cb6eadb",
"id": "45973566-31d2-06f1-e063-6294a90a7c4b",
"effective_time": "20251210",
"version": "5",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"CVS childrens Cough and Cold"
],
"generic_name": [
"CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR"
],
"manufacturer_name": [
"CVS PHARMACY"
],
"product_ndc": [
"51316-745"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"CHLORPHENIRAMINE MALEATE",
"DEXTROMETHORPHAN HYDROBROMIDE"
],
"rxcui": [
"1111440"
],
"spl_id": [
"45973566-31d2-06f1-e063-6294a90a7c4b"
],
"spl_set_id": [
"035c5e2a-04e3-490b-8f1a-233a5cb6eadb"
],
"package_ndc": [
"51316-745-04"
],
"is_original_packager": [
true
],
"unii": [
"V1Q0O9OJ9Z",
"9D2RTI9KYH"
]
}
}
]
}