Topco Associates LLC. Mucus ER Drug Facts

TopCare Mucus ER by

Drug Labeling and Warnings

TopCare Mucus ER by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOPCARE MUCUS ER- guaifenesin tablet, extended release 
Topco Associates LLC

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Topco Associates LLC. Mucus ER Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 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 (1-800-222-1222).

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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • store between 20°-25°C (68°-77°F)
  • do not use if printed foil under cap is broken or missing

Inactive ingredients

colloidal silicon dioxide, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

12 HOUR

Mucus-ER

Maximum Strength

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

EXPECTORANT

Relieves Chest Congestion

Thins and Loosens Mucus

actual size

COMPARE TO MAXIMUM STRENGTH MUCINEX®™ active ingredient

14 EXTENDED-RELEASE TABLETS

TopCare Mucus ER image
TOPCARE MUCUS ER 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 36800-325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeOVAL (Biconvex) Size22mm
FlavorImprint Code Watson;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 36800-325-661 in 1 CARTON07/14/201601/30/2019
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09100907/14/201601/30/2019
Labeler - Topco Associates LLC (006935977)

Revised: 12/2019
Document Id: a36712b3-951f-4045-ba49-a50133c101e8
Set id: 67680619-0dd0-4d29-a103-b9134f0f21ca
Version: 2
Effective Time: 20191216
 
Topco Associates LLC