630t Walgreens 0363-0775 Maximum Strength Daytime & Nighttime Cold And Flu

630t Walgreens 0363-0775 Maximum Strength Daytime & Nighttime Cold And Flu
SPL v3
SPL
SPL Set ID da2a77c3-7d0f-157b-e053-2995a90a951a
Route
ORAL
Published
Effective Date 2021-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Guaifenesin (200 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide D&c Yellow No. 10 Fd&c Blue No. 1 Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Imprint: 72 Shape: oval Color: orange Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 softgels in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks daily 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 or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.



Indications and Usage

Uses

• temporarily relieves these common cold and flu symptoms:

sinus congestion and pressure

cough

minor aches and pains

headache

nasal congestion

sore throat

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes due to hay fever

• controls cough to help you get to sleep

• temporarily reduces fever



Dosage and Administration

Directions

• do not take more than directed (see Overdose warning)

• do not take more than 12 softgels in any 24-hour period

• adults and children 12 years of age and older: take 2 softgels every 4 hours.

• children under 12 years of age: do not use

Description

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Section 44425-7

Other information

• store at 20-25°C (68-77°F)

• avoid excessive heat



Section 50565-1

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• pain, nasal congestion, or cough gets worse or lasts more than 7 days

• fever gets worse, or lasts more than 3 days

• redness or swelling is present

• new symptoms occur

• cough comes back, or occurs with fever, 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


• excitability may occur, especially in children

• marked drowsiness may occur

• alcohol, sedatives, and tranquilizers may increase drowsiness

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery



Section 50568-5

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers



Section 50569-3

Ask a doctor before use if you have

• liver disease

• heart disease

• diabetes

• high blood pressure

• thyroid disease

• trouble urinating due to enlarged prostate gland

• glaucoma

• a breathing problem such as emphysema or chronic bronchitis

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough that occurs with too much phlegm (mucus)



Section 50570-1

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). 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.



Section 51727-6

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 53413-1

Questions or Comments?

Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant



Section 55106-9

Active ingredients (in each softgel)

Acetaminophen 325 mg


Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg



Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses

• temporarily relieves these common cold and flu symptoms:

sinus congestion and pressure

cough

minor aches and pains

headache

nasal congestion

sore throat

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes due to hay fever

• controls cough to help you get to sleep

• temporarily reduces fever



Dosage and Administration (34068-7)

Directions

• do not take more than directed (see Overdose warning)

• do not take more than 12 softgels in any 24-hour period

• adults and children 12 years of age and older: take 2 softgels every 4 hours.

• children under 12 years of age: do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 softgels in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks daily 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 or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.



Section 44425-7 (44425-7)

Other information

• store at 20-25°C (68-77°F)

• avoid excessive heat



Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• pain, nasal congestion, or cough gets worse or lasts more than 7 days

• fever gets worse, or lasts more than 3 days

• redness or swelling is present

• new symptoms occur

• cough comes back, or occurs with fever, 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


• excitability may occur, especially in children

• marked drowsiness may occur

• alcohol, sedatives, and tranquilizers may increase drowsiness

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery



Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers



Section 50569-3 (50569-3)

Ask a doctor before use if you have

• liver disease

• heart disease

• diabetes

• high blood pressure

• thyroid disease

• trouble urinating due to enlarged prostate gland

• glaucoma

• a breathing problem such as emphysema or chronic bronchitis

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough that occurs with too much phlegm (mucus)



Section 50570-1 (50570-1)

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). 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.



Section 51727-6 (51727-6)

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 53413-1 (53413-1)

Questions or Comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant



Section 55106-9 (55106-9)

Active ingredients (in each softgel)

Acetaminophen 325 mg


Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg



Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)