MUCUS RELIEF MAXIMUM STRENGTH- guaifenesin tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
P & L Development, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Expectorant Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
Authorization status:
Abbreviated New Drug Application
Authorization number:
59726-832-14

MUCUS RELIEF MAXIMUM STRENGTH- guaifenesin tablet

P & L Development, LLC

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Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 mg

Purpos e

Expectorant

Us es

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 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 20º to 25ºC (68º to 77ºF)

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: PL Developments

200 Hicks Street, Westbury, NY 11590

Package Label

WELLNESS BASICS Maximum Streng th Mucus Relief

MUCUS RELIEF MAXIMUM STRENGTH

guaifenesin tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 726 -8 32

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

120 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

P & L Development, LLC

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

OVAL

S iz e

22mm

Flavor

Imprint Code

AN0 37

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 726 -8 32-14

14 in 1 CARTON

0 3/31/20 19

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 7342

0 3/31/20 19

Labeler -

P & L Development, LLC (800014821)

Revised: 5/2019

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