guaifenesin extended-release tablets, 600 mg and 1200 mg

guaifenesin extended-release tablets, 600 mg and 1200 mg
SPL v8
SPL
SPL Set ID e3531e9e-2ae7-4188-b95a-90f35613fc05
Route
oral
Published
Effective Date 2021-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (600 mg)
Inactive Ingredients
hypromellose 2910 (5 mpa.s) carbomer homopolymer type b (allyl sucrose crosslinked) sodium starch glycolate type a potato magnesium stearate microcrystalline cellulose hypromellose 2910 (10000 mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 16 mm Size: 22 mm Score: 1
Marketing Status
anda active Since 2020-12-18

Purpose

Expectorant

Description

Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 1200 mg)


Medication Information

Warnings

Do not use

  • for children under 12 years of age
Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Expectorant

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 timing of meals
  • adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (For 600 mg)
  • 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. (For 1200 mg)
  • children under 12 years of age: do not use
Other Information

  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)
Inactive Ingredients

carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate

Description

Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 1200 mg)

Principal Display Panel

Questions?

Contact 1-877-770-3183



Mon-Fri 8:00 AM EST to 5:00 PM PST.

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.
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)

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)
Principal Display Panel 600 Mg Blister Carton Label

NDC 62207- 839-72 Compare to the active ingredient

of Mucinex ®

Guaifenesin

Extended-Release Tablets 600 mg

Guaifenesin 600 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAYRelieves Chest Congestion

OR NIGHT Thins and Loosens Mucus

Immediate and Extended Release

90 (9 x 10) EXTENDED-RELEASE TABLETS

Principal Display Panel 1200 Mg Blister Carton Label

NDC 62207- 840-71 Compare to the active ingredient

of Mucinex ®

Guaifenesin

Extended-Release Tablets 1200 mg

Maximum strength

Guaifenesin 1200 mg - Expectorant



RELIEVES CHEST CONGESTION

12HR FOR DAY • Relieves Chest Congestion

OR NIGHT • Thins and Loosens Mucus

• Immediate and Extended Release

70 (7 x 10) EXTENDED-RELEASE TABLETS

Active Ingredients ​(in Each Extended Release Tablet)

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)


Structured Label Content

Warnings

Do not use

  • for children under 12 years of age
Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose (purpose)

Expectorant

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 timing of meals
  • adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (For 600 mg)
  • 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. (For 1200 mg)
  • children under 12 years of age: do not use
Other Information (Other information)

  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions?

Contact 1-877-770-3183



Mon-Fri 8:00 AM EST to 5:00 PM PST.

Stop Use and Ask A Doctor If (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.
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 (1-800-222-1222)

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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)
Principal Display Panel 600 Mg Blister Carton Label (PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton Label)

NDC 62207- 839-72 Compare to the active ingredient

of Mucinex ®

Guaifenesin

Extended-Release Tablets 600 mg

Guaifenesin 600 mg - Expectorant

RELIEVES CHEST CONGESTION

12HR FOR DAYRelieves Chest Congestion

OR NIGHT Thins and Loosens Mucus

Immediate and Extended Release

90 (9 x 10) EXTENDED-RELEASE TABLETS

Principal Display Panel 1200 Mg Blister Carton Label (PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton Label)

NDC 62207- 840-71 Compare to the active ingredient

of Mucinex ®

Guaifenesin

Extended-Release Tablets 1200 mg

Maximum strength

Guaifenesin 1200 mg - Expectorant



RELIEVES CHEST CONGESTION

12HR FOR DAY • Relieves Chest Congestion

OR NIGHT • Thins and Loosens Mucus

• Immediate and Extended Release

70 (7 x 10) EXTENDED-RELEASE TABLETS

Active Ingredients ​(in Each Extended Release Tablet) (Active ingredients ​(in each extended-release tablet))

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)