COUGH OUT- guaifenesin liquid

Cough Out by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: (In each teaspoonful 5 mls)         Purpose

Guiafenesin 100 mg (USP)............................................Expectorant

PURPOSE

Purpose Expectorant

INDICATIONS & USAGE

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

WARNINGS

Warnings

Do not exceed recommended dosage

Ask a doctor before use if you have

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

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persstent headached. A persistent cough may be a sign of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children.

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions:

Shake well immediately before use.

Do not exceed 6 doses in any 24 hour period. 

Adults and Children 12 years and over - 10 ml (2 tsps) every 4 hours

Children 6 to under 12 years of age - 5 ml (1 tsp) every 4 hours

Children under 6 years of age - Do not use

INACTIVE INGREDIENT

Inactive Ingredients:Aloe Vera, Aspartame, Honey, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water

OTHER SAFETY INFORMATION

Each 5 mls contains: sodium 5 mg, and potassium 5 mg

Phenylketonurics: Contains Phenylalanine 2.5 mg per 5 ml (teaspoonful). 

QUESTIONS

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH OUT 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-255
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HONEY (UNII: Y9H1V576FH)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
ASPARTAME (UNII: Z0H242BBR1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-255-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/1997
2	NDC: 58593-255-06	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/1997

Labeler - Efficient Laboratories Inc. (969044932)

Registrant - Efficient Laboratories Inc. (969044932)