Guaifenesin 200mg
45ac210a-8c54-4469-8e10-e6fe52b89cb5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact
Purpose
Expectorant Guaifenesin 200 mg Tablets
Medication Information
Purpose
Expectorant
Guaifenesin 200 mg Tablets
Description
GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Section 42229-5
GUAIFENESIN 200 MG TABLETS
Marlex Pharmaceuticals, Inc.
----------
Drug Fact
Warnings
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)
Directions:
- Do not take more than 6 doses in any 24-hour period.
- This product is not intended for use in children under 12 years of age
- Adults & children 12 years and over: 1 to 2 tablets every 4 hours
- Children under 12 years: do not use
Other Information:
- Store at 15°C-30°C (59°F-86°F)
Inactive Ingredients:
Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid
Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev: 02/19TCL
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 200 mg |
| 3000 | 71610-434-18 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20200619JH
Stop Use and Ask A Doctor If
cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding
ask a health professional before use.
Principal Display Panel 200 Mg
NDC 71610-434 - Guaifenesin 200 mg Tablets
Active Ingredient (in Each Tablet)
Guaifenesin 200mg
Structured Label Content
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Section 42229-5 (42229-5)
GUAIFENESIN 200 MG TABLETS
Marlex Pharmaceuticals, Inc.
----------
Drug Fact
Purpose
Expectorant
Guaifenesin 200 mg Tablets
Warnings
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)
Directions:
- Do not take more than 6 doses in any 24-hour period.
- This product is not intended for use in children under 12 years of age
- Adults & children 12 years and over: 1 to 2 tablets every 4 hours
- Children under 12 years: do not use
Other Information:
- Store at 15°C-30°C (59°F-86°F)
Inactive Ingredients:
Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid
Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev: 02/19TCL
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 200 mg |
| 3000 | 71610-434-18 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20200619JH
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Keep Out of Reach of Children (Keep out of reach of children)
In case of overdose, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding (If pregnant or breast- feeding)
ask a health professional before use.
Principal Display Panel 200 Mg (PRINCIPAL DISPLAY PANEL - 200 mg)
NDC 71610-434 - Guaifenesin 200 mg Tablets
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Guaifenesin 200mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:18.441678 · Updated: 2026-03-14T23:06:55.199519