Kroger Guaifenesin Extended Release Tablets 1200 Mg

Kroger Guaifenesin Extended Release Tablets 1200 Mg
SPL v2
SPL
SPL Set ID 100ff8e2-88ed-0e8c-e063-6294a90a5716
Route
ORAL
Published
Effective Date 2024-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Hypromellose, Unspecified Microcrystalline Cellulose 102 Stearic Acid Fd&c Blue No. 1 Aluminum Lake Sodium Starch Glycolate Type A Maltodextrin Povidone K30 Silicon Dioxide Copovidone K25-31 Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 41 Shape: capsule Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-27

Description

Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg


Medication Information

Indications and Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration

Directions

  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use
Description

Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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 illness.

Section 50569-3

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)

Section 50570-1

Do not use

  • for children under 12 years of age
Section 51727-6

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid.

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-632-6900

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration (34068-7)

Directions

  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use
Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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 illness.

Section 50569-3 (50569-3)

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)

Section 50570-1 (50570-1)

Do not use

  • for children under 12 years of age
Section 51727-6 (51727-6)

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-632-6900

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)