Acetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu

Set ID
d06ffed7-0914-45fa-afe7-90477bb1d16b
Manufacturer
Velocity Pharma
Effective date
2014-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:10

Key Label Information

Active Ingredients And Purpose

Active Ingredient

(in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

pain reliever Cough Suppressant Nasal decongestant

Uses

Uses

pain reliever, cough suppressant and Nasal decongestant

Warnings

Warnings

Warnings Failure to follow these warnings could result in serious consequences. Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 4 doses in 24 hours which is maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product do not use: with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug, If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease Heart disease Thyroid disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland ask your 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: Redness or swelling is present You get nervous, dizzy or sleepless Fever gets worse or lasts more than 3 days New symptoms occur Symptoms do not get better within 7 days or are accompanied by a fever

Directions And Dosage

Direction

do not exceed 4 doses per 24 hours take only as directed – see overdose warning Adults and children 12 years and over: 2 softgels with water every 4 hours children under 12 years: ask a doctor Children under 4 years: do not use

Other Label Information

Inactive Ingredients

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Questions or Comments

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76168-055-02 12 softgels

Products

NDC Codes

Ingredients

NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Complete SPL Sections

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

pain reliever Cough Suppressant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

pain reliever, cough suppressant and Nasal decongestant

Warnings

WARNINGS SECTION

Warnings Failure to follow these warnings could result in serious consequences. Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 4 doses in 24 hours which is maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product do not use: with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug, If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease Heart disease Thyroid disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland ask your 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: Redness or swelling is present You get nervous, dizzy or sleepless Fever gets worse or lasts more than 3 days New symptoms occur Symptoms do not get better within 7 days or are accompanied by a fever

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a health professional before use. Overdose warning : Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Direction

DOSAGE & ADMINISTRATION SECTION

do not exceed 4 doses per 24 hours take only as directed – see overdose warning Adults and children 12 years and over: 2 softgels with water every 4 hours children under 12 years: ask a doctor Children under 4 years: do not use

Other Information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Questions or Comments

OTC - QUESTIONS SECTION

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76168-055-02 12 softgels

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otcb3bacaef-5dd7-4237-a327-ed4ee33274ee.xml2014-05-01
otcb3bacaef-figure-01.jpg2014-05-01