GUAIFENESIN DM- guaifenesin and dextromethorphan syrup 
American Health Packaging

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GUAIFENESIN and DEXTROMETHORPHAN SYRUP
Drug Facts

Active ingredient (in each 5 mL Cup)

Guaifenesin 100 mg
Dextromethorphan Hydrobromide 10 mg

Purpose

Expectorant
Cough Suppressant

Uses

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.
  • you are hypersensitive to any of the ingredients.

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

Follow dosage below or use as directed by a physician.

Age (yr)

Dose (mL)

adults and children 12 years and over

10 mL (2 teaspoonfuls) every 4 hours

children 6 years to under 12 years

5 mL (1 teaspoonful) every 4 hours

children 2 years to under 6 years

2.5 mL (1/2 teaspoonful) every 4 hours

children under 2 years

ask a doctor

Other Information

Inactive Ingredients

citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Questions or comments?

Call 1-800-845-8210

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).

Distributed by:
American Health Packaging
Columbus, OH 43217

R0324

Package/Label Principal Display Panel - Label

GUAIFENESIN and DEXTROMETHORPHAN SYRUP Label

Case NDC 60687-817-17/Cup NDC 60687-817-40

GUAIFENESIN and
DEXTROMETHORPHAN
SYRUP

Expectorant/Cough Suppressant

100 mg/10 mg per 5 mL

Non-Narcotic, Alcohol Free
Cherry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0638C050324                 R03/24

Package/Label Principal Display Panel – Cup Lid – 100 mg/10 mg per 5 mL

GUAIFENESIN and DEXTROMETHORPHAN SYRUP Cup Lid

NDC 60687- 817-40

Guaifenesin and
Dextromethorphan Syrup

Expectorant/cough Suppressant

100 mg/10 mg per 5 mL

Delivers 5 mL

Protect from light

See package Drug Facts insert for full
prescribing information and storage

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0638C050224

GUAIFENESIN DM 
guaifenesin and dextromethorphan syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-817
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (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)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-817-1710 in 1 CASE08/04/2024
1NDC:60687-817-4610 in 1 TRAY
1NDC:60687-817-405 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 DrugM01208/04/2024
Labeler - American Health Packaging (929561009)

Revised: 8/2024
Document Id: 1d755574-97e5-8933-e063-6294a90a1e61
Set id: 990906b3-c566-4f35-923c-060202ba48e0
Version: 1
Effective Time: 20240804
 
American Health Packaging