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Sorbutuss NR

Medically reviewed by Drugs.com. Last updated on Dec 9, 2020.

Dosage form: liquid
Ingredients: GUAIFENESIN 100mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL
Labeler: Teral Inc.
NDC Code: 68436-120

FULL PRESCRIBING INFORMATION

Active Ingredients

Each 7.5 mL. Contains (1 1/2 tsp)

Dextromethorphan HBr 15 mg......Antitussive

Glyceryl Guaiacolate 150 mg....Expectorant

Purpose Section

Antitusive

Expectorant

These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval
  • For the temporary relief of cough due to minor throat and bronchial irritation as may occur with a cold.
  • Helps loosen phlegm (mucus) and thin bronchial secretions to makes cough more productive.

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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before use if you have
  • Chronic cough that last such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • Cough that occurs with too much phlegm (mucus).

Stop use and ask a doctor if
  • Cough last for more than 7 days comes back or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Pregnancy or breast feeding section

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

Keep out of reach of children

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

These highlights do not include all the information needed to use

Follow dosage below or use as directed by a doctor. Do not exceed 6 doses in a 24 hours period.

Adults and children 12 years and older 2 teaspoonfuls every 4 hours

Children 6 years to under 6 years 1 teaspoonful every 4 hours

Children 2 years to 6 years 1/2 teaspoonful every 4 hours

Children under 2 years Consult a doctor

Other information

Store at room temperature 15º-30º C (59º - 86º F)

Inactive Ingredients

Artificial and Natural Flavors, Glycerin, Methylparaben, Potassium Citrate, Propylparaben, Purified Water, Sorbitol and Sucralose

Questions or Comments?

Teral, Inc. (787) 383-2781 Fax (787) 284-9082

Safety Information

Do not accept if safety seal around bottle cap is broken or missing

Expiration Date information

Lot:

Exp:

Rev:12/06

Principal Panel

NDC 68436-120-16

Sorbutuss NR

Antitussive-Expectorant

Does Not Containt

Antihistamines

Decongestants

Sodium

With

Sucralose

Sugar Free Alcohol Free

Dye Free

Grape Flavor

16 oz. fl. oz. (474 mL)

Manufacture for

Teral, Inc.

Ponce, P.R. 00731

SORBUTUSS  NR
sorbutuss liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68436-120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (with Sucralose) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68436-120-16474 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2007
Labeler - Teral Inc. (186958810)
Registrant - Teral Inc (186958810)
Establishment
NameAddressID/FEIOperations
Dextrum Laboratories, Inc007392322manufacture(68436-120)
Establishment
NameAddressID/FEIOperations
Teral, Inc186958810label(68436-120)

 
Teral Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.