Label: COLD AND COUGH RELIEF CHILDREN- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
- NDC Code(s): 70677-0121-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 November 15, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- Purposes
-
Uses
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily restores freer breathing through the nose
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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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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Directions
- do not take more than 6 doses in a 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use - Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S DIMETAPP® COLD & COUGH
Children's
Cold & Cough Relief
Relieves itchy, watery eyes, cough, runny nose, sneezing, stuffy nose, itching of the nose or throat
For ages 6 years and over
Alcohol-free
BROMPHENIRAMINE MALEATE 2 MG
ANTIHISTAMINE
DEXTROMETHORPHAN HBr 10 MG
COUGH SUPPRESSANT
PHENYLEPHRINE HCl 5 MG
NASAL DECONGESTANT
GRAPE FLAVOR
fl oz (mL)
Dosing Cup Included
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by McKesson Corp.
6555 State Highway 161 Irving, TX 75039
- Package Label
-
INGREDIENTS AND APPEARANCE
COLD AND COUGH RELIEF CHILDREN
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-0121-1 1 in 1 BOX 10/30/2020 1 118 mL in 1 BOTTLE, PLASTIC; 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 10/30/2020 Labeler - Strategic Sourcing Services LLC (116956644)
