ULTRA TUSS SAFE- guaifenesin dextromethorphan hbr syrup

Ultra Tuss Safe by

Drug Labeling and Warnings

Ultra Tuss Safe by is a Otc medication manufactured, distributed, or labeled by Ultra Seal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (In 5 ml)

Guaifenesin   100 mg

Dextromethorphann HBr 10 mg

PURPOSE

Purpose: Expectorant, Antitussive (Anti Cough)

INDICATIONS & USAGE

Uses: temporarily:

helps loosen phlegm (mucus)

 thin bronchial secretions to drain bronchial tubes, and make coughs more productive.

    restores free breathing

    suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

more than the recommended dose.

Stop use and ask a doctor if:

symptoms do not improve within 7 days or are accompanied by fever

cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Ask a doctor before use if you have:

a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a healthprofessional 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions:

Do not exceed 6 doses in any 24 hour period.

Adults and children 12 years of age and older: Take 2 teaspoons (10 ml) every 4 hours as needed, or as directed by a doctor.

Children 6-12 years: Take 1 teaspoon ( 5 ml) every 4 hours as needed, or as directed by a doctor.

Not to be used for children under 6 years of age.

INACTIVE INGREDIENT

Inactive Ingredients: Citric Acid, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA TUSS SAFE 
guaifenesin dextromethorphan hbr syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42213-162
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (sweet cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42213-162-83	1 in 1 CARTON	06/19/2012
1	NDC: 42213-162-86	119 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/19/2012

Labeler - Ultra Seal Corporation (085752004)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(42213-162)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(42213-162)