GUAIFENESIN AND DEXTROMETHORPHAN- guaifenesin and dextromethorphan syrup 
Major Pharmaceuticals

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Guaifenesin Syrup and Dextromethorphan
Syrup
Expectorant/Cough Suppressant

DRUG FACTS

Active ingredient (in each 5 mL cup)                                                                                                                    Purpose

                                                                                                                                                                   

Guaifenesin 100 mg .............................................................................................................................. Expectorant
Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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

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 out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

Follow dosage below or use as directed by a physician.
 do not take more than 6 doses in any 24-hour period.
 single use cup. Dose only with cup provided.
 each cup delivers 5 mL
 mL = Milliliter

Age (yr) Dose (mL)
adults and children
12 years and over

10 mL every 4 hours

children 6 years to under 12 years 5 mL every 4 hours 
children under 6 years of ageask a doctor

Other information

Each 5 mL contains: sodium 4 mg.
 Store at 20° to 25°C (68° to 77°F). Protect from light.

Inactive ingredients:

anhydrous citric acid, FD&C Red No. 40, flavor, glycerin, menthol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sucrose.

Questions or comments?

Call1-800-845-8210

How Supplied

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

R10/24

Distributed by:

MAJOR® PHARMACEUTICALS
Indianapolis, IN  46268

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

Delivers 5 mL
NDC   0904-7512-41

GUAIFENESIN and DEXTROMETHORPHAN
Syrup

100 mg/10 mg per 5 mL

See Insert for Drug Facts
For Institutional Use Only

Guaifenesin and DM Syrup-Lid
GUAIFENESIN AND DEXTROMETHORPHAN 
guaifenesin and dextromethorphan syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7512
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MENTHOL (UNII: L7T10EIP3A)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7512-7010 in 1 CASE02/10/2025
110 in 1 TRAY
1NDC:0904-7512-415 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/10/2025
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2025
Document Id: 7a9d1e3e-d1ad-4b40-9f77-6df15fecacc2
Set id: 97b137c9-0bec-409a-91f7-e298c296578b
Version: 4
Effective Time: 20250129
 
Major Pharmaceuticals