FDA.reportPublic FDA data

Maximum Strength Mucus Relief Plus Pain and Headache

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:27

Label at a glance#

ProductMaximum Strength Mucus Relief Plus Pain and Headache
Active ingredientACETAMINOPHEN, GUAIFENESIN
Label structure14 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin 

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981 (toll-free)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ValuRx

Maximum Strength 

Mucus Relief +
Pain & Headache

Carton

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN2
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD2
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130383059000208GTIN-13: 0383059000208
EAN-13: 0383059000208
GTIN-12: 383059000208
UPC-A: 383059000208
GTIN storage (14 digits): 00383059000208		Carton.jpg
QR code linkQR Codewww.shieldpharmacorp.com/Carton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0052-1Maximum Strength Mucus Relief Plus Pain and Headache1 in 1 CARTONCAPSULE, LIQUID FILLED12
83059-0052-1Maximum Strength Mucus Relief Plus Pain and Headache10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-005283059-0052-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSES3NXW29V3WOIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
SORBITOL SOLUTION8KW3E207O2IACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus Relief Plus Pain and HeadacheACETAMINOPHEN, GUAIFENESINShield Pharmaceuticals Corpf20c0db1-dcf3-4bfc-b3e4-930398f82dc92026-05-06WarningsExact identifier
ndc (package): 83059-0052-1
ndc (product): 83059-0052
ndc11 (package): 83059005201
spl id: 512e5fbc-c0bb-d4d0-e063-6294a90a3dc4
spl set id: f20c0db1-dcf3-4bfc-b3e4-930398f82dc9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.