ULTRA TUSS- guaifenesin syrup

Ultra Tuss by

Drug Labeling and Warnings

Ultra Tuss 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

PURPOSE

Purpose: Expectorant

INDICATIONS & USAGE

Uses: temporarily:

 helps loosen phlegm (mucus)

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

WARNINGS

Warnings:

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Do not use:

more than the recommended dose.

Stop use and ask a doctor if:

symptoms do not improve

new symptoms occur

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 health proffessional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDEREN. 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 childern even if you do not notice any signs or smptoms.

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, FD& C Red 40, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Purified water, Sodium Citrate, Sodium Saccharin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA TUSS  
guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42213-160
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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42213-160-93	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2012

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(42213-160)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(42213-160)