MAXIMUM STRENGTH MUCUS RELIEF PLUS PAIN AND HEADACHE- acetaminophen, guaifenesin capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg
Guaifenesin 200 mg

Purpose

Pain reliever/fever reducer
Expectorant

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 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day

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.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin 

When using this product do not use more than directed

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning:Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

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

Other information

• store at 20-25ºC (68-77ºF)
• avoid excessive heat

Questions or comments?

1-800-373-6981 (toll-free)

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

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

ValuRx

Maximum Strength 

Mucus Relief +
Pain & Headache

Carton

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MUCUS RELIEF PLUS PAIN AND HEADACHE 
acetaminophen, guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83059-0052
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)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	MPH
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83059-0052-1	1 in 1 CARTON	05/06/2026
1		10 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 Drug	M012	05/06/2026

Labeler - Shield Pharmaceuticals Corp (118724924)