ASSURED™ MAXIMUM STRENGTH MUCUS RELIEF

Set ID
0d811f94-16b1-4ba8-aeea-6f947b69ba24
Manufacturer
SPIRIT PHARMACEUTICALS LLC | MEDGEL PRIVATE LTD
Effective date
2016-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:45

Key Label Information

Uses

Uses

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

Warnings

Warnings

Directions And Dosage

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 older: take 2 liquid gels every 4 hours children under 12 years of age: do not use

Other Label Information

Other information

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

Inactive ingredients

FD&C yellow no. 6, FD&C red no.40, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, purified water

Questions or Comments?

Call 1-888-333-9792

PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton

COMPARE TO ACTIVE INGREDIENTS IN MUCINEX ® FAST-MAX ® COLD, FLU & SORE THROAT* ASSURED ™ MAXIMUM STRENGTH Mucus Relief Acetaminophen 325 mg - Pain Reliever / Fever Reducer Dextromethorphan HBr 10 mg - Cough Suppressant Guaifenesin 200 mg - Expectorant Phenylephrine HCl 5 mg - Nasal Decongestant Thins & Loosens Mucus, Nasal Congestion, Coughing, Fever & Headache Non-Drowsy Actual Size AGES 12+ 10 softgels

Products

NDC Codes

Ingredients

NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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 older: take 2 liquid gels every 4 hours children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow no. 6, FD&C red no.40, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, purified water

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-333-9792

PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS IN MUCINEX ® FAST-MAX ® COLD, FLU & SORE THROAT* ASSURED ™ MAXIMUM STRENGTH Mucus Relief Acetaminophen 325 mg - Pain Reliever / Fever Reducer Dextromethorphan HBr 10 mg - Cough Suppressant Guaifenesin 200 mg - Expectorant Phenylephrine HCl 5 mg - Nasal Decongestant Thins & Loosens Mucus, Nasal Congestion, Coughing, Fever & Headache Non-Drowsy Actual Size AGES 12+ 10 softgels

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/0d811f94-16b1-4ba8-aeea-6f947b69ba24/d77bec74-2c20-4af8-ab25-de94be40f298.xml
XML SHA-256
9fbac9576bc91bad8797e38195023192cdcb24867f7d6aa6869a86b2199ab064
XML bytes
35206

Legacy File Index

FolderFileDate
otcassured-01.jpg2016-08-12
otcd77bec74-2c20-4af8-ab25-de94be40f298.xml2016-08-12