Label: CHILDRENS METAPP DAYTIME- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
- NDC Code(s): 53041-577-03
- Packager: Guardian Drug Company
- 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 January 13, 2022
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- Active ingredients (in each 5 mL tsp)
- Purposes
- KEEP OUT OF REACH OF CHILDREN
-
Uses
- temporarily relieves cough due to minor bronchial irritation as may occur 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):
- sneezing
- itching of the nose or throat
- runny nose
- itchy, watery eyes
- temporarily restores freer breathing through the nose
-
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 parkinsons 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
- glaucoma
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination 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 as 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 take more than directed
- may cause drowsiness
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcohol beverages
- be careful when driving a motor vehicle or operating mahcinery
- excitability may occur, especially in children
- Directions
- Other information
- Inactive ingredients
-
PDP
Compare to the active ingredients in Childrens Dimetapp
Childrens Metapp Daytime
Cold & Cough
Brompheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
Relieves:
- Nassal Congestion
- Soothes Cough
- Calms allergies
Alcohol Free
For ages 6 years and over
Grape
4 FL OZ (118 mL)
-
INGREDIENTS AND APPEARANCE
CHILDRENS METAPP DAYTIME
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53041-577 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 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) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color purple Score Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53041-577-03 1 in 1 CARTON 06/06/2012 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 06/06/2012 Labeler - Guardian Drug Company (119210276)