GUAIFENESIN 1200 MG AND PSEUDOEPHEDRINE HCL 120 MG- guaifenesin and pseudoephedrine hcl tablet, extended release

Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg by

Drug Labeling and Warnings

Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg by is a Otc medication manufactured, distributed, or labeled by Wal-mart Stores, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each extended-release tablet)

Guaifenesin USP, 1200 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant 

Purpose

Expectorant and Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• temporarily relieves sinus congestion and pressure

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to an enlarged prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough accompanied by too much phlegm (mucus)

When using this product

• do not use more than directed

Stop use and ask doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
• adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: do not use

Other information

• tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
• store between 20° - 25°C (68° - 77°F)

Inactive ingredients

FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

Questions?

call 1-888-375-3784

You may also report side effect to this phone number.

Principal Display Panel

INGREDIENTS AND APPEARANCE

GUAIFENESIN 1200 MG AND PSEUDOEPHEDRINE HCL 120 MG 
guaifenesin and pseudoephedrine hcl tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-261(NDC:55111-799)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	1200 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	120 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	RDY;799
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-261-24	4 in 1 CARTON	04/03/2020	04/03/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49035-261-12	2 in 1 CARTON	04/03/2020
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208369	04/03/2020

Labeler - Wal-mart Stores, Inc. (051957769)