Drug Facts
7b23faa9-40c8-4cea-b9fb-487cce2664af
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Guaifenesin 400mg
How Supplied
Guaifenesin and Dextromethorphan Hydrobromide 400 mg/20 mg Tablets NDC 71335-2216-1: 30 Tablets in a BOTTLE NDC 71335-2216-2: 20 Tablets in a BOTTLE NDC 71335-2216-3: 18 Tablets in a BOTTLE NDC 71335-2216-4: 60 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Medication Information
Dosage and Administration
Directions
■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
■ Children under 6 years of age: consult a doctor.
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
How Supplied
Guaifenesin and Dextromethorphan Hydrobromide 400 mg/20 mg Tablets
- NDC 71335-2216-1: 30 Tablets in a BOTTLE
- NDC 71335-2216-2: 20 Tablets in a BOTTLE
- NDC 71335-2216-3: 18 Tablets in a BOTTLE
- NDC 71335-2216-4: 60 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
Description
Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Guaifenesin 400mg
Uses
■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Center immediately.
Section 50566-9
Stop use and ask doctor if
■ symptoms are accompanied by fever, rash or persistent headache
■ cough persists for more than 1 week or tends to recur.
A persistent cough may be a sign of a serious condition.
Section 50569-3
Ask doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ cough is accompanied by excessive phlegm (mucus)
Section 51727-6
Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.
Section 51945-4
Guaifenesin and Dextromethorphan Hydrobromide 400mg/20mg Tablet
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Cough Suppressant
Expectorant
Section 55106-9
Active ingredient - (per tablet)
Dextromethorphan Hydrobromide 20mg
Guaifenesin 400mg
Warnings
Do not use ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.
Other Information
Store at 15°-30°C (59°-86°F)
Structured Label Content
Uses
■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.
Dosage and Administration (34068-7)
Directions
■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
■ Children under 6 years of age: consult a doctor.
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Center immediately.
Section 50566-9 (50566-9)
Stop use and ask doctor if
■ symptoms are accompanied by fever, rash or persistent headache
■ cough persists for more than 1 week or tends to recur.
A persistent cough may be a sign of a serious condition.
Section 50569-3 (50569-3)
Ask doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ cough is accompanied by excessive phlegm (mucus)
Section 51727-6 (51727-6)
Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.
Section 51945-4 (51945-4)
Guaifenesin and Dextromethorphan Hydrobromide 400mg/20mg Tablet
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Cough Suppressant
Expectorant
Section 55106-9 (55106-9)
Active ingredient - (per tablet)
Dextromethorphan Hydrobromide 20mg
Guaifenesin 400mg
Warnings
Do not use ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.
How Supplied (HOW SUPPLIED)
Guaifenesin and Dextromethorphan Hydrobromide 400 mg/20 mg Tablets
- NDC 71335-2216-1: 30 Tablets in a BOTTLE
- NDC 71335-2216-2: 20 Tablets in a BOTTLE
- NDC 71335-2216-3: 18 Tablets in a BOTTLE
- NDC 71335-2216-4: 60 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
Other Information
Store at 15°-30°C (59°-86°F)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:38.193806 · Updated: 2026-03-14T23:07:45.169331