MUCINEX COLD AND FLU- acetaminophen, guaifenesin capsule, liquid filled

Mucinex Cold and Flu by

Drug Labeling and Warnings

Mucinex Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Acetaminophen 325 mg.............Pain reliever/fever reducer
Guaifenesin 200 mg...............................................Expectorant

Uses

Uses
■ temporarily relieves these common cold and flu symptoms:
■ minor aches and pains
■ headache ■ sore throat
■ helps loosen phlegm (mucus) and thin bronchial secretions
to rid the bronchial passageways of bothersome mucus
and make coughs more productive
■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
■ more than 12 liquid gels in 24 hours, which is the
maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right
away.
Sore throat warning: If sore throat is severe, persists for
more than 2 days, is accompanied or followed by fever,
headache, rash, nausea, or vomiting, consult a doctor
promptly.

Directions

■ do not take more than directed (see Overdose warning)
■ do not take more than 12 liquid gels in any 24-hour period
■ adults and children 12 years of age and over: take
2 liquid gels every 4 hours
■ children under 12 years of age: do not use

Other Information

■ store at 20-25°C (68-77°F)
■ avoid excessive heat

Inactive Ingredients

FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light
mineral oil, polyethylene glycol, povidone, propylene glycol,
purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

1-866-MUCINEX (1-866-682-4639)

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Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
©2021 RB Health

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Principal Display Panel

Fast Dissolving Liquid Gels!

NDC: 72854-136-16

Mucinex®

COLD, FLU

Acetaminophen – Pain Reliever/Fever Reducer
Guaifenesin – Expectorant

✓Thins & Loosens Mucus
✓Relieves Sore Throat, Headache & Chest Congestion
✓Reduces Fever

16
LIQUID GELS
(Liquid Filled Capsules)

Actual Size

DAY TIME
FOR AGES 12+

INGREDIENTS AND APPEARANCE

MUCINEX COLD AND FLU 
acetaminophen, guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-136
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	23mm
Flavor		Imprint Code	AR09
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-136-16	2 in 1 CARTON	07/01/2022
1		8 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
OTC monograph final	part341	07/01/2022

Labeler - RB Health (US) LLC (081049410)