DailyMed - ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution

NDC Code(s): 0904-7441-20
Packager: Major Pharmaceuticals

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated April 8, 2025

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Active ingredients (in each 20 mL)
Dextromethorphan HBr 20 mg - Guaifenesin 200 mg

Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
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Purpose
Cough suppressant - Expectorant

Cough suppressant
Expectorant
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Uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold - helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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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 ...
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)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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.

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Directions
do not take more than directed - do not take more than 6 doses in any 24-hour period - mL = milliliter - only use the dose cup provided - adults and children 12 years and over: 20 mL every 4 ...
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 20 mL every 4 hours
- children under 12 years: do not use
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Other information
each 20 mL contains: sodium 8 mg - store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
- each 20 mL contains: sodium 8 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
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Inactive ingredients
anhydrous citric acid, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucralose, xanthan gum

anhydrous citric acid, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucralose, xanthan gum
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Questions or comments?
1-800-426-9391

1-800-426-9391
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Principal display panel
MAJOR® NDC 0904-7441-20 - Compare to the active - ingredients in Robitussin® Sugar-Free Dye-Free - Cough+Chest Congestion DM* Sugar Free & Dye Free - Robafen® DM - Cough - Dextromethorphan ...

MAJOR®

NDC 0904-7441-20
Compare to the active
ingredients in Robitussin®
Sugar-Free Dye-Free
Cough+Chest Congestion DM*

Sugar Free & Dye Free
Robafen® DM
Cough
Dextromethorphan HBr
Guaifenesin
Cough Suppressant
Expectorant

Oral Solution

• Controls Cough
• Relieves Chest Congestion
• Thins & Loosens Mucus

Ages 12 Years and Over

Cool Mint Flavored

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

*This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,
owner of the registered trademark Robitussin® Sugar-Free
Dye-Free Cough+Chest Congestion DM.
50844 ORG062307336

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

Major 44-073

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(0904-7441) , pack(0904-7441)

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Published Date (What is this?)	Version	Files
Apr 14, 2025	2 (current)	download
Apr 8, 2024	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1790650	dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution	PSN
2	1790650	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution	SCD
3	1790650	dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution	SY
4	1790650	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution	SY
5	1790650	dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution	SY

Label: ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution

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Drug Label Info

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Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution

Number of versions: 2

ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution

ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution

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ROBAFEN DM COUGH- dextromethorphan hbr, guaifenesin solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.