Mucinex: Package Insert and Label Information

MUCINEX- guaifenesin tablet, extended release
REMEDYREPACK INC.

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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

Warnings

Do not use

  • for children under 12 years of age

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)

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.

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

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

Directions

  • do not crush, chew, or break 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Mucinex®

600 mg guaifenesin
extended-release bi-layer tablets

NDC: 70518-0228-00 20 in 1 BOTTLE PLASTIC

NDC: 70518-0228-01 20 in 1 BLISTER PACK

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Mucinex

GENERIC: Guaifenesin

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0228-0

NDC: 70518-0228-1

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: Mucinex;600

PACKAGING: 20 in 1 BOTTLE, PLASTIC

PACKAGING: 20 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • Guaifenesin 600mg in 1

INACTIVE INGREDIENT(S):

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • HYPROMELLOSE, UNSPECIFIED
  • ALUMINUM OXIDE
  • FD&C BLUE NO. 1
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
Remedy_LabelMM2Remedy_LabelMM2
MUCINEX
guaifenesin tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0228(NDC:63824-008)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 600 mg
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C BLUE NO. 1
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (blue and white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Mucinex;600
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0228-0 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:70518-0228-1 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021282 02/16/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 04/2020 REMEDYREPACK INC.

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