Label: CHILDRENS COUGH AND COLD- chlorpheniramine maleate, dextrometrorphan hbr liquid
- NDC Code(s): 55319-754-04
- Packager: FAMILY DOLLAR SERVICES INC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 16, 2023
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- DRUG FACTS
- Active ingredients (in each 10 mL)
- Purposes
-
WARNINGS
Do not use
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- to sedate a child or to make a child sleepy
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- 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
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- glaucoma
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- a cough that occurs with too much phlegm (mucus)
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- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product
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- do not use more than directed
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- 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.
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
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- measure only with dosing cup provided
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- keep dosing cup with product
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- mL = milliliter
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- 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
- Inactive ingredients
- QUESTIONS OR COMMENTS?
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Prinipal Display of Packaging
Compare to the active ingredients in Children’s Robitussin® Cough & Cold Long–Acting*
NDC 55319-754-04
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
- •
- No Added alcohol
- 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:
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INGREDIENTS AND APPEARANCE
CHILDRENS COUGH AND COLD
chlorpheniramine maleate, dextrometrorphan hbr liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-754 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (chlorpheniramine - UNII:3U6IO1965U) chlorpheniramine maleate 2 mg in 10 mL dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide 15 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED Score Shape Size Flavor FRUIT PUNCH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-754-04 1 in 1 CARTON 05/08/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/08/2023 Labeler - FAMILY DOLLAR SERVICES INC (024472631)