MUCUS RELIEF- guaifenesin tablet
PLD Acquisitions LLC DBA Avéma Pharma Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Avema Pharma Solutions

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

Warnings

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied with excessive phlegm (mucus)

When using this product

do not exceed recommended dosage
do not use for more than 7 days

Stop use and ask a doctor if

cough lasts more than 7 days, recurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care 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

adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed more than 6 doses in 24 hours.
children under 12 years of age: do not use

Other information

each tablet contains: Sodium 5 mg VERY LOW SODIUM
store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate and stearic acid.

Questions or Comments?

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

Product Label

NDC 63548-0007-1

Mucus Relief

Guaifenesin, 400 mg

Expectorant

• Helps relieve chest congestion

• Helps thin and loosens Mucus

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

PL Developments

200 Hicks street

Westbury, NY 11590

Product Label

Mucus Relief

MUCUS RELIEF
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63548-0007
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	TCL272;G1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63548-0007-1	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/18/2011	02/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	01/18/2011	02/28/2017

Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017

Document Id: 4bfc4f8a-cda9-4736-bf83-d2525f166230

Set id: 9ee3f4ee-d849-4246-9ac7-aff3145fe9fb

Version: 2

Effective Time: 20170329

PLD Acquisitions LLC DBA Avéma Pharma Solutions