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Cough by Rebel Distributors Corp

Medically reviewed on February 9, 2018

Dosage form: liquid
Ingredients: Guaifenesin 100mg in 5mL
Labeler: Rebel Distributors Corp
NDC Code: 21695-705

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Rugby®
Cough
SYRUP

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 over2–4 teaspoonfuls
children 6 to under 12 years1–2 teaspoonfuls
children under 6 yearsdo 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

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

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)

COUGH 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-705(NDC:0536-0825)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Caramel 
Citric Acid Monohydrate 
Corn Syrup 
FD&C RED NO. 40 
Glycerin 
Menthol 
Propylene Glycol 
Water 
Sodium Benzoate 
Saccharin Sodium 
Product Characteristics
ColorPINK (Reddish-Pink) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-705-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/04/2009
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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