ALTIPRES PEDIATRIC- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Altipres by

Drug Labeling and Warnings

Altipres by is a Otc medication manufactured, distributed, or labeled by Alternative Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant

Guaifenesin .............................. 75 mg ................ Expectorant

Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

WARNINGS

Warnings

Ask a doctor before use if your child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to the enlargement of the prostate gland
• a cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product, do not exceed recommended dosage

Stop use and ask doctor if

• your child gets nervous, dizzy or sleepless
• symptoms do not get better 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

DO NOT USE

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 taking this product -Do not use- in a child under 2 years of age.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Indications

• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold
  
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves nasal congestion due to the common cold
  

DOSAGE & ADMINISTRATION

Directions  Do not exceed more than 6 doses in any 24-hour period

• adults and children 12 years of age and over: take 4 teaspoonfuls (20 mL) every 4 hours
• children 6 to under 12 years of age: take 2 teaspoonful (10 mL) every 4 hours
• children 2 years to under 6 years of age: take 1 teaspoonful (5 mL) every 4 hours
• children under 2 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

QUESTIONS

Questions or comments? 1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALTIPRES  PEDIATRIC
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53163-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (Orange Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53163-103-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2013

Labeler - Alternative Pharmacal Corporation (078528214)