day time cold & flu relief

day time cold & flu relief
SPL v3
SPL
SPL Set ID c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c
Route
oral
Published
Effective Date 2024-01-05
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 2018-01-01

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Drug Facts


Medication Information

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ■ more than

4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing

acetaminophen ■ 3 or more alcoholic drinks everyday while usina 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

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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

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

children 4 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.

Other Information

■ sodium content per tablespoon: 10 mg

■ store at room temperature

Inactive Ingredients

citric acid, FD&C Yellow # 6, Made in USA flavor, glycerin, propylene glycol, purified water,

saccharin sodium, sodium benzoate, sucrose

Description

Drug Facts

Questions?

Call weekdays from 9:30 AM to

4:30 PM EST at 1-877-798-5944

Section 42229-5

Drug Facts

Section 50565-1

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

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. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ 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.

Overdose Warning:

Taking more than the recommended dose (overdose) may

cause liver damage. In case of accidental 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.

Active Ingredients

Acetaminophen               325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI        5 mg

When Using This Product

■ do not use more than directed (see overdose

warning) ■ avoid alcoholic drinks

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 couldbe signs of a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

Ask A Doctor Before Use If You Have

■ liver disease ■ heart disease ■ thyroid disease ■ diabetes

■ high blood pressure ■ trouble urinating due to enlarged prostrate 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 you are taking the blood thinning

drug warfarin

Product Package Label Day Time Cold & Flu Relief

AP SAFE

*COMPARE TO

the active ingredients in

VICKS® DAYQUIL®

Day Time

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCI – Nasal Decongestant

Cold & Flu Relief

Multi-Symptom Relief

12 FL OZ (354 mL)



*This product is not manufactured or distributed by Procter &

Gamble, owner of the registered trademark Vicks® DayQuil®.

Manufactured by: AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

           LOT:                                  EXP:

12 OZ

res


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ■ more than

4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing

acetaminophen ■ 3 or more alcoholic drinks everyday while usina 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

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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

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

children 4 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.

Other Information (Other information)

■ sodium content per tablespoon: 10 mg

■ store at room temperature

Inactive Ingredients

citric acid, FD&C Yellow # 6, Made in USA flavor, glycerin, propylene glycol, purified water,

saccharin sodium, sodium benzoate, sucrose

Questions?

Call weekdays from 9:30 AM to

4:30 PM EST at 1-877-798-5944

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Do Not Use (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. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ 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.

Overdose Warning:

Taking more than the recommended dose (overdose) may

cause liver damage. In case of accidental 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.

Active Ingredients

Acetaminophen               325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI        5 mg

When Using This Product (When using this product)

■ do not use more than directed (see overdose

warning) ■ avoid alcoholic drinks

Stop Use and Ask A Doctor If (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 couldbe signs of a serious condition.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ liver disease ■ heart disease ■ thyroid disease ■ diabetes

■ high blood pressure ■ trouble urinating due to enlarged prostrate 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 (Ask a doctor or pharmacist before use)

if you are taking the blood thinning

drug warfarin

Product Package Label Day Time Cold & Flu Relief (Product Package Label - Day Time Cold & Flu Relief)

AP SAFE

*COMPARE TO

the active ingredients in

VICKS® DAYQUIL®

Day Time

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCI – Nasal Decongestant

Cold & Flu Relief

Multi-Symptom Relief

12 FL OZ (354 mL)



*This product is not manufactured or distributed by Procter &

Gamble, owner of the registered trademark Vicks® DayQuil®.

Manufactured by: AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

           LOT:                                  EXP:

12 OZ

res


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