These Highlights Do Not Include All The Information Needed To Use Sorbutuss. See Full Prescribing Information For Initial U.s. Approval

These Highlights Do Not Include All The Information Needed To Use Sorbutuss. See Full Prescribing Information For Initial U.s. Approval
SPL v8
SPL
SPL Set ID 304f1d5a-218c-51ae-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2007-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Potassium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-01

Description

Each 7.5 mL. Contains (1 1/2 tsp) Dextromethorphan HBr 15 mg......Antitussive Glyceryl Guaiacolate 150 mg....Expectorant

Purpose

Antitusive Expectorant


Medication Information

Purpose

Antitusive Expectorant

Description

Each 7.5 mL. Contains (1 1/2 tsp) Dextromethorphan HBr 15 mg......Antitussive Glyceryl Guaiacolate 150 mg....Expectorant

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.

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

Purpose Section

Antitusive

Expectorant

Other Information

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

Active Ingredients

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

Dextromethorphan HBr 15 mg......Antitussive

Glyceryl Guaiacolate 150 mg....Expectorant

Safety Information

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

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

Expiration Date Information

Lot:

Exp:

Rev:12/06

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.
Keep Out of Reach of Children

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

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).
Pregnancy Or Breast Feeding Section

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

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

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.

Structured Label Content

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.

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

Purpose Section

Antitusive

Expectorant

Other Information (Other information)

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

Active Ingredients

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

Dextromethorphan HBr 15 mg......Antitussive

Glyceryl Guaiacolate 150 mg....Expectorant

Safety Information

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

Inactive Ingredients

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

Questions Or Comments? (Questions or Comments?)

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

Expiration Date Information (Expiration Date information)

Lot:

Exp:

Rev:12/06

Stop Use and Ask A Doctor If (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.
Keep Out of Reach of Children (Keep out of reach of children)

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

Ask A Doctor Before Use If You Have (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).
Pregnancy Or Breast Feeding Section (Pregnancy or breast feeding section)

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

These Highlights Do Not Include All the Information Needed to Use (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

These Highlights Do Not Include All the Information Needed to Use Sorbutuss. See Full Prescribing Information for Initial U.s. Approval (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.

Advanced Ingredient Data


Raw Label Data

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