DailyMed - MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

NDC Code(s): 17856-1162-1
Packager: ATLANTIC BIOLOGICALS CORP.
This is a repackaged label.
Source NDC Code(s): 0536-1161

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 17, 2025

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Active ingredients (in each extended-release tablet)
Dextromethorphan HBr 30 mg - Guaifenesin 600 mg

Dextromethorphan HBr 30 mg

Guaifenesin 600 mg
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Purpose
Cough Suppressant - Expectorant

Cough Suppressant

Expectorant
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Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive - temporarily relieves - cough due to minor throat ...
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves
  - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  - the intensity of coughing
  - the impulse to cough to help you get to sleep
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Description
Mucus Relief DM ER - Guaifenesin 600 mg (Expectorant) Dextromethorphan HBr 30 mg (Cough Suppressant) 12-hour Relief - Controls Cough - Thins & Loosens Mucus - Extended-release tablets, compared to ...
Mucus Relief DM ER

Guaifenesin 600 mg (Expectorant)

Dextromethorphan HBr 30 mg (Cough Suppressant)
- 12-hour Relief
- Controls Cough
- Thins & Loosens Mucus
Extended-release tablets, compared to the active ingredients in Mucinex DM.

TAMPER EVIDENT: DO NOT USE IF THE BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING

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Warnings
Do not use - for children under12 years of age - if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or ...
Do not use
- for children under12 years of age
- 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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
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 occurs with 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).

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Directions
do not crush, chew, or break tablet - take with a full glass of water - this product can be administered without regards for timing of meals - adults and children 12 years of age and older: 1 or 2 ...
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regards for timing of meals
- adults and children 12 years of age and older: 1 or 2 tablet every 12 hours; not more than 4 tablets in 24 hours
- children under 12 years of age: do not use
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Other information
store between 20º to 25ºC (68º to 77ºF)

store between 20º to 25ºC (68º to 77ºF)
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Inactive ingredients
carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc
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Questions or comments?
DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. 20101 NE 16TH PL - MIAMI, FL 33179 - Call1-800-509-7592 - Monday-Friday 9 AM - 5 PM EST

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PL

MIAMI, FL 33179

Call1-800-509-7592

Monday-Friday 9 AM - 5 PM EST

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Package Label

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Solutions		360804194	repack(17856-1162)

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Published Date (What is this?)	Version	Files
Mar 27, 2025	4 (current)	download
Mar 21, 2025	2	download

	RxCUI	RxNorm NAME	RxTTY
1	1298324	guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet	PSN
2	1298324	12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet	SCD
3	1298324	dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY

Label: MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

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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

When using this product,

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: MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

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

When using this product,

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

MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

Number of versions: 2

MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

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MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

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