TUSSIN ORIGINAL- guaifenesin liquid 
Major Pharmaceuticals

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.

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Drug Facts

Active ingredients

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin
bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have
• cough that occurs with too much phlegm
(mucus) • cough that lasts or is chronic such as
occurs with smoking, asthma, chronic bronchitis,
or emphysema

When using this product

do not use more than directed

Stop use and ask a doctor if

cough lasts more than 7 days, comes back,
or is accompanied by fever, rash, or persistent
headache. These could be signs of a serious
condition.

If pregnant or breast-feeding

ask a health
professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek
professional assistance or contact a Poison
Control Center immediately.

Directions

do not exceed 6 doses in a 24-hour period
• this adult product is not intended for use in
children under 12 years of age


adults and children 12 years and over      2-4 teaspoonfuls (tsps) every 4 hours
      
children under 12 years do not use

Other information

store at controlled room temperature
• dosage cup provided
• alcohol-free

Inactive ingredients

caramel, citric acid, flavor, glucose, glycerin,
high fructose corn syrup, menthol, purified water,
red 40, saccharin sodium, sodium benzoate

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TUSSIN ORIGINAL 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCARAMEL (caramel) , CHERRY (cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-0061-20118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/200910/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/07/200910/01/2017
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2017
 
Major Pharmaceuticals