MUCA CLEAR- guaifenesin tablet 
Schwabe North America, Inc

----------

Muca Clear

Active Ingredient

Guaifenesin 200 mg

Inactive Ingredient

carnauba wax

cellulose

dextrin

fenugreek (Trigonella foenum-graecum) (seed) extract

glycerin

hypromellose

magnesium stearate

maltodextrin

marshmallow (Althaea officinalis) (root) extract

mullein (Verbascum thapsus) (leaf) extract

povidone

silica

sodium croscarmellose

stearic acid

Dosage & Administration

adults & children 12 years of age and older:  take 1-2 tablets every 4 hours, not to exceed 12 tablets in 24 hours

children 6 - 11 years of age: take 1/2 - 1 tablet every 4 hours not to exceed 6 tablets in 24 hours

children under 6 years of age:  consult a doctor before use

Purpose

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

Indications & Usage

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

Warnings

Do not use this product if you are pregnant, attempting to be pregant, or breast-feeding.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Ask Doctor

Ask a doctorbefore use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough that is accompanied by excessive phlegm (mucus), diabetes, been taking any medications.

Stop Use

Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompnaied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Keep out of reach of children

Keep out of reach of children.

Overdosage

In case of overdose, seek medical help or contact a Poison Control Center immediately.

LZP13653.H02-Muca-Clear-(OTC)-100-tabs.jpg

Add image transcription here...

MUCA CLEAR 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59800-1365
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
FENUGREEK SEED (UNII: 654825W09Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MULLEIN LEAF (UNII: 9936O846LI)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorbrown (pale yellow to brown with specks) Scoreno score
ShapeOVAL (Convex face, debossed 232 tablet) Size20mm
FlavorImprint Code 232
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59800-1365-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/24/2020
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc831153908manufacture(59800-1365)

Revised: 11/2023
Document Id: ef847088-ee15-4977-a333-cac0a4ccbe19
Set id: 735128ad-6844-4a8e-83d0-29cbb5d66f4a
Version: 5
Effective Time: 20231121
 
Schwabe North America, Inc