COUGH- guaifenesin liquid

Cough by

Drug Labeling and Warnings

Cough by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin 100 mg

Uses

helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Warnings

Ask a doctor before use if you have

• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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

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

Directions

• take every four hours
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 2–4 teaspoonfuls
• children 6 to under 12 years: 1–2 teaspoonfuls
• children under 6 years: do not use

Other information

• each teaspoonful contains: sodium 3 mg
• store at room temperature 15°–30°C (59°–86°F)

Inactive ingredients

caramel powder, citric acid, corn syrup, FD&C red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

QUESTIONS

1-800-645-2158, 9 am – 5 pm ET, Monday – Friday

PURPOSE

TAMPER EVIDENT

DO NOT USE IF INNER FOIL SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Rebel Distributors Corp
NDC: 21695-705-04

• FOR ADULTS AND CHILDREN
• NON-NARCOTIC EXPECTORANT
• ALCOHOL FREE

Cough
SYRUP
Guaifenesin, USP

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

COUGH 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-705(NDC:0536-0825)
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
Caramel (UNII: T9D99G2B1R)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Corn Syrup (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Menthol (UNII: L7T10EIP3A)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color	PINK (Reddish-Pink)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-705-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/04/2009

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK