ALTITUSS- dextromethorphan hbr, guaifenesin liquid

Altituss by

Drug Labeling and Warnings

Altituss 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 7.5 mL)                Purpose

Dextromethorphan HBr.............. 15 mg ........ Cough suppressant

Glyceryl Guaiacolate .................. 150 mg ...... Expectorant

PURPOSE

Purpose

Cough suppressant

Expectorant

INDICATIONS & USAGE

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

WARNINGS

Warnings

DO NOT USE

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 you are taking a prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

 Cough that occurs with too much phlegm (mucus)

Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product do not use more than directed.

Stop use and ask a doctor before use if: 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health profession 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.

DOSAGE & ADMINISTRATION

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

• Adults and children 12 years of age and over: 10 ml (2tsp) every 4 hours
• Children 6 years to under 12 years of age: 5 ml (1tsp) every 4 hours
• Children 2 years to under 6 years of age: 2.5 ml (1/2 tsp) every 4 hours
• Children under 2 years: Consult a doctor

INACTIVE INGREDIENT

Inactiveingredients

Citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

QUESTIONS

Questions or comments? 1-786-507-1566

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALTITUSS 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53163-113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 7.5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	150 mg  in 7.5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53163-113-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2015

Labeler - Alternative Pharmacal Corporation (078528214)