PEDIA RELIEF chlorpheniramine maleate and pseudoephedrine hydrochloride dextromethorphan hydrobromide liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

Chlorpheniramine maleate

Composition:

Chlorpheniramine maleate 1 mg in 5 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

PEDIA RELIEF- CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE
HYDROCHLORIDE AND
DEXTROMETHORPHAN HYDROBROMIDE LIQUID
PREFERRED PHARMACEUTICALS INC.
_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._
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PEDIA RELIEF™
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH 2 TSP (10_
_ML))_
_PURPOSES_
Chlorpheniramine maleate, USP 2 mg
Antihistamine
Dextromethorphan HBr, USP 10 mg
Cough suppressant
Pseudoephedrine HCl, USP 30 mg
Nasal decongestant
US ES
temporarily relieves these symptoms of the common cold, hay fever or
other upper respiratory
allergies:
1.
2.
3.
4.
5.
6.
WARNINGS
DO NOT USE in a child who is 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 child's
prescription drug contains an MAOI, ask a
doctor or pharmacist before giving this product.
ASK A DOCTOR BEFORE USE IF CHILD HAS
1.
2.
3.
4.
5.
6.
7.
8.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS taking sedatives
or tranquilizers
WHEN USING THIS PRODUCT
cough
nasal congestion
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
a breathing problem such as chronic bronchitis
cough that occurs with too much phlegm (mucus)
chronic cough that lasts such as occurs with asthma
heart disease
thyroid disease
glaucoma
diabetes
high blood pressure
1.
2.
3.
4.
STOP USE AND ASK A DOCTOR IF
1.
2.
3.
KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or
contact a Poison Control
Center right away.
DIRECTIONS
1.
2.
3.
AGE
DOSE
Children 6 to 11 years
2 TSP
Children under 6 years
Do not use
OTHER INFORMATION
1.
INACTIVE INGREDIENTS
artificial cherry flavor, citric acid, FD&C red #40, glycerin,
propylene glycol, purified water, sodium
benzoate, sodium citrate, sorbitol solution
QUESTIONS OR COMMENTS?
1-800-616-24