Non-Drowsy Daytime Severe Cold Multi-Symptom

Set ID
529bc1ae-a1b2-4984-8757-33ba65071441
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:12

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each caplet)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

Uses

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

Warnings

Warnings

Liver warning : This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. 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 for followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions And Dosage

Directions

do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Other Label Information

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

D&C Yellow#10, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide *may contain this ingredient

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

DAYTIME NON-DROWSY SEVERE COLD MULTI-SYMPTOM • Acetaminophen - Pain Reliever / Fever Reducer • Dextromethorphan HBr - Cough Suppressant • Guaifenesin- Expectorant • Phenylephrine HCl - Nasal Decongestant 12 caplets

Products

NDC Codes

Ingredients

NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
POVIDONEFZ989GH94EIACT

Complete SPL Sections

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning : This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. 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 for followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow#10, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAYTIME NON-DROWSY SEVERE COLD MULTI-SYMPTOM • Acetaminophen - Pain Reliever / Fever Reducer • Dextromethorphan HBr - Cough Suppressant • Guaifenesin- Expectorant • Phenylephrine HCl - Nasal Decongestant 12 caplets

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc2929990b-33c1-b1a9-e063-6394a90a7302.xml2024-12-15
otc0c02da0c-d1b3-a118-e063-6294a90adbd8.xml2023-12-09
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otcc5ee92e1-e3a7-f7e9-e053-2995a90ae991.xml2021-06-30
otcRR.jpg2021-06-30