ALTITUSS- dextromethorphan hbr, guaifenesin liquid 
Alternative Pharmacal Corporation

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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Active Ingredients (in each 7.5 mL)                Purpose

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

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

Purpose

Cough suppressant

Expectorant

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

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.

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

 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

Inactiveingredients

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

Questions or comments? 1-786-507-1566

Altituss Label

ALTITUSS 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 7.5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN150 mg  in 7.5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53163-113-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2015
Labeler - Alternative Pharmacal Corporation (078528214)

Revised: 12/2020
Document Id: b4509f15-c100-4010-ac0f-63b145214671
Set id: e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44
Version: 4
Effective Time: 20201223
 
Alternative Pharmacal Corporation