MUCUS RELIEF MAXIMUM STRENGTH- guaifenesin tablet 
Care One (American Sales Company)

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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 makes 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 accopanied 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

Other information

Inactive ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Maximum Strength Mucinex®*

MAXIMUM STRENGTH

MUCUS RELIEF

Guaifenesin 1200 mg

Expectorant

12 HOUR RELIEF

RELIEVES CHEST CONGESTION

THINS AND LOOSENS MUCUS

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex®.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Package Label

Guaifenesin 1200 mg

CARE ONE Mucus Relief

MUCUS RELIEF  MAXIMUM STRENGTH
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-732
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CARBOMER 934 (UNII: Z135WT9208)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize22mm
FlavorImprint Code AN037
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-732-1414 in 1 CARTON12/31/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20734212/31/2018
Labeler - Care One (American Sales Company) (809183973)

Revised: 11/2022
Document Id: 72cc5e09-dd68-4158-935a-4fa739235045
Set id: c94e3943-20da-4bd4-b0ff-6aa60b03a1bf
Version: 3
Effective Time: 20221121
 
Care One (American Sales Company)