Guaifenesin Caplets, 200 Mg

Guaifenesin Caplets, 200 Mg
SPL v2
SPL
SPL Set ID 2ae3c1e1-2a12-444d-a763-590320d373e1
Route
ORAL
Published
Effective Date 2018-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg)
Inactive Ingredients
Fd&c Red No. 40 Silicon Dioxide Magnesium Stearate Cellulose, Microcrystalline Maltodextrin Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AP;151 Shape: round Color: red Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-03-01
Description

Guaifenesin 200 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 200 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus and make cough more productive
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 excessive phlegm (mucus)
Directions:
  • adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years: do not use
Other  Information
  • store at 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

colloidal silicon dioxide, FD&C RED#40(Al-lake), magnesium stearate, maltodextrin,  microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions Or Comments

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

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 71610-098-18

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



20180718JH

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 serious illness

Keep Out of Reach of Children 

In case of overdose, get medical help or contact a Poison Control Center right away.

Principal Display Panel 200 Mg

NDC 71610-098 - Guaifenesin 200 mg - Rx Only

Active Ingredient (in Each Tablet)

Guaifenesin 200 mg

In Case of Pregnancy Or Breast Feeding Section

ask a health professional before use

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus and make cough more productive
Purpose

Expectorant

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 excessive phlegm (mucus)
Directions:
  • adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years: do not use
Other  Information (OTHER  INFORMATION)
  • store at 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C RED#40(Al-lake), magnesium stearate, maltodextrin,  microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions Or Comments (Questions or Comments)

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

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 71610-098-18

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



20180718JH

Stop Use and Ask A Doctor (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 serious illness

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.

Principal Display Panel 200 Mg (PRINCIPAL DISPLAY PANEL - 200 mg)

NDC 71610-098 - Guaifenesin 200 mg - Rx Only

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 200 mg

In Case of Pregnancy Or Breast Feeding Section (IN CASE OF PREGNANCY OR BREAST FEEDING SECTION)

ask a health professional before use

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:37.751123 · Updated: 2026-03-14T22:55:14.803903