CHILDRENS METAPP DAYTIME- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Childrens Metapp Daytime by

Drug Labeling and Warnings

Childrens Metapp Daytime by is a Otc medication manufactured, distributed, or labeled by Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL tsp)

Brompheniramine maleate 1 mg
Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

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

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
• 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. 

Directions

• do not take more than 6 doses in any 24-hour period
• do not exceed recommended dosage

• Age: Dose
• adults and children 12 years and over: 4 tsp (20 mL) every 4 hours
• children 6 to under 12 years: 2 tsp (10 mL) every 4 hours
• children under 6 years: do not use

Other information

• each teaspoon (tsp) contains: sodium 5 mg
• store at 20-25oC (68-77oF)
• measuring cup provided

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C BLUE #1, FD&C red 40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

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 liquid

Product 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)