SPL v5
SPL
SPL Set ID e181b371-78c7-4163-865d-acc064be33ca
Route
ORAL
Published
Effective Date 2020-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-09-05

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCL 5 mg


Medication Information

Warnings and Precautions

Warnings

Liver Warning: The product contains acetaminophen. Severe liver

damage may occur if ■ adult takes more than 4doses (30 mL each)

in 24 hours, which is the maximum daily amount for this product ■

child takes more than 4 doses (15 mL each) in 24 hours, which is the

maximum daily amount for this product ■ taken with other drugs

containing acetaminophen ■ adult has 3 or more alcoholic drinks

every day while using the 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.

Indications and Usage

Uses temporarily relieves these common cold/flu symptoms:

  • minor aches and pains ● headache ● sore throat ● fever
  • nasal congestion ● cough due to minor throat and bronchial irritation
Dosage and Administration

Directions ● take only as recommended (see overdose warning)

  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours

                 age                                                        dose

adults and children 12 years and over             30 mL (2 TBSP) every 4 hours

children 6 years to under 12 years                 15 mL (1 TBSP) every 4 hours

children 4 years to under 6 years                   ask a doctor

children under 4 years                                 do not use

  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCL 5 mg

Section 34088-5

Overdose Warning: Taking more than the recommended dose (overdose)

could cause serious health problems, including liver damage. In case of

accidental overdose, seek professional assistance or contact a Poison

Control Center immediately. Quick medical attention is critical for adults

as well as for children even if you do not notice any signs or symptoms.

Section 50565-1

Keep this and all drugs out of the reach of children.

Section 50566-9

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur

● fever gets worse or lasts more than 3 days

● pain or cough gets worse or lasts more than 5 days (children) or

7 days (adults) • redness or swelling is present

● cough comes back or occurs with rash or headache that lasts. These

could be signs of a serious condition.

Section 50567-7

When using this product •do not use more than directed (see overdose warning) • avoid alcoholic drinks

Section 50568-5

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
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use  if the user is taking the blood thinning drug warfarin

Section 50570-1

Do not use • 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 two weeks after stopping

the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a

pharmacist before taking this product.

• with any other drug containing acetaminophen (prescription or non-prescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

Section 51727-6

Inactive ingredients

citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified

water, saccharin sodium, sodium benzoate, sucrose

Section 53414-9

If pregnant of breast-feeding ask a health profesional before use.

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 60561-8

Other information

  • sodium content per tablespoon: 10 mg
  • store at room temperature
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Day Time Product Label

COMPARE TO

VICKS® DAYQUIL®

ACTIVE INGREDIENTS

CVP®

DAY TIME

NON-DROWSY COLD/FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer

Dextromethorphan HBr……Cough Suppressant

Phenylephrine HCL ……. Nasal Decongestant

6 FL OZ (177 mL)

Failure to follow these warnings could result in serious consequences

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or

distributed by Proctor and Gamble, owner of

the registered trademark Vicks® Dayquil®.

Questions? Call weekdays from 9:30am

to 4:30pm EST at 1-877-798-5944

LR-038 Rev 03

Distributed by:

Salado Sales, Inc.

P.O. Box 6115

Temple, Tx 76503

www.saladosales.com

LOT:       EXP:

RES


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves these common cold/flu symptoms:

  • minor aches and pains ● headache ● sore throat ● fever
  • nasal congestion ● cough due to minor throat and bronchial irritation
Dosage and Administration (34068-7)

Directions ● take only as recommended (see overdose warning)

  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours

                 age                                                        dose

adults and children 12 years and over             30 mL (2 TBSP) every 4 hours

children 6 years to under 12 years                 15 mL (1 TBSP) every 4 hours

children 4 years to under 6 years                   ask a doctor

children under 4 years                                 do not use

  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
Warnings and Precautions (34071-1)

Warnings

Liver Warning: The product contains acetaminophen. Severe liver

damage may occur if ■ adult takes more than 4doses (30 mL each)

in 24 hours, which is the maximum daily amount for this product ■

child takes more than 4 doses (15 mL each) in 24 hours, which is the

maximum daily amount for this product ■ taken with other drugs

containing acetaminophen ■ adult has 3 or more alcoholic drinks

every day while using the 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.

Section 34088-5 (34088-5)

Overdose Warning: Taking more than the recommended dose (overdose)

could cause serious health problems, including liver damage. In case of

accidental overdose, seek professional assistance or contact a Poison

Control Center immediately. Quick medical attention is critical for adults

as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur

● fever gets worse or lasts more than 3 days

● pain or cough gets worse or lasts more than 5 days (children) or

7 days (adults) • redness or swelling is present

● cough comes back or occurs with rash or headache that lasts. These

could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product •do not use more than directed (see overdose warning) • avoid alcoholic drinks

Section 50568-5 (50568-5)

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
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use  if the user is taking the blood thinning drug warfarin

Section 50570-1 (50570-1)

Do not use • 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 two weeks after stopping

the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a

pharmacist before taking this product.

• with any other drug containing acetaminophen (prescription or non-prescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

Section 51727-6 (51727-6)

Inactive ingredients

citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified

water, saccharin sodium, sodium benzoate, sucrose

Section 53414-9 (53414-9)

If pregnant of breast-feeding ask a health profesional before use.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Section 60561-8 (60561-8)

Other information

  • sodium content per tablespoon: 10 mg
  • store at room temperature
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Day Time Product Label (Day Time product label)

COMPARE TO

VICKS® DAYQUIL®

ACTIVE INGREDIENTS

CVP®

DAY TIME

NON-DROWSY COLD/FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer

Dextromethorphan HBr……Cough Suppressant

Phenylephrine HCL ……. Nasal Decongestant

6 FL OZ (177 mL)

Failure to follow these warnings could result in serious consequences

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or

distributed by Proctor and Gamble, owner of

the registered trademark Vicks® Dayquil®.

Questions? Call weekdays from 9:30am

to 4:30pm EST at 1-877-798-5944

LR-038 Rev 03

Distributed by:

Salado Sales, Inc.

P.O. Box 6115

Temple, Tx 76503

www.saladosales.com

LOT:       EXP:

RES


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)