SORBUTUSS NR- sorbutuss liquid

Sorbutuss by

Drug Labeling and Warnings

Sorbutuss by is a Otc medication manufactured, distributed, or labeled by Teral,Inc, Teral Inc, Dextrum Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• HIGHLIGHTS OF PRESCRIBING INFORMATION

  These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval

  INDICATIONS AND USAGE

  • 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.

  DOSAGE AND ADMINISTRATION

  Follow dosage below or use as directed by a doctor. Do not exceed 6 doses in a 24 hours period. (8)

  (8)

  Adults and children 12 years and older 2 teaspoonfuls every 4 hours (8)

  (8)

  Children 6 years to under 6 years 1 teaspoonful every 4 hours (8)

  (8)

  Children 2 years to 6 years 1/2 teaspoonful every 4 hours (8)

  (8)

  Children under 2 years Consult a doctor (8)

  Revised: 1/2007

• Table of Contents

  FULL PRESCRIBING INFORMATION: CONTENTS*

  Active Ingredients

  Purpose Section

  These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval

  Warnings

  Ask A Doctor Before use if you have

  Stop use and ask a doctor if

  Pregnancy or breast feeding section

  Keep out of reach of children

  These highlights do not include all the information needed to use

  * Sections or subsections omitted from the full prescribing information are not listed.

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

INGREDIENTS AND APPEARANCE

SORBUTUSS  NR
sorbutuss liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68436-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CITRATE (UNII: EE90ONI6FF)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68436-120-16	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2007

Labeler - Teral Inc. (186958810)

Registrant - Teral Inc (186958810)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories, Inc		007392322	manufacture(68436-120)

Establishment
Name	Address	ID/FEI	Business Operations
Teral, Inc		186958810	label(68436-120)