Non Drowsy Severe Daytime And Severe Nighttime Cold And Flu Relief

Non Drowsy Severe Daytime And Severe Nighttime Cold And Flu Relief
SPL v4
SPL
SPL Set ID 8624a453-42bd-4876-9f7e-0cfc618a0984
Route
ORAL
Published
Effective Date 2022-11-10
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 Red No. 40 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 Shellac Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Imprint: 116;A07 Shape: oval Color: orange Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-10

Description

Non Drowsy Severe Daytime Cold and Flu Relief

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Non Drowsy Severe Daytime Cold and Flu Relief

Uses

■ temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure

■ cough due to minor throat & bronchial irritation

■ minor aches & pains ■ headache

■ fever ■ sore throat ■ reduces swelling of nasal passages

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 53414-9

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings

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

■ 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 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 or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

■ take only as directed - see Overdose warning

■ do not exceed 4 doses per 24 hours

adults & children 12 years & over 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

■ when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

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.

Drug Facts

Non Drowsy Severe Daytime Cold and Flu Relief

Drug Facts 

Severe Nighttime Cold and Flu Relief

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

■ store at room temperature

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

Call toll free: 1-888-333-9792

Principal Display Panel

When Using This Product

■ do not use more than directed

■ excitability may occur, especially in children

■ marked drowsiness may occur ■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

■ you get nervous, dizzy or sleepless

■ 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 rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have

■ liver disease ■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

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

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin


Structured Label Content

Uses

■ temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure

■ cough due to minor throat & bronchial irritation

■ minor aches & pains ■ headache

■ fever ■ sore throat ■ reduces swelling of nasal passages

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings

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

■ 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 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 or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

■ take only as directed - see Overdose warning

■ do not exceed 4 doses per 24 hours

adults & children 12 years & over 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

■ when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Do Not Use (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.

Drug Facts

Non Drowsy Severe Daytime Cold and Flu Relief

Drug Facts 

Severe Nighttime Cold and Flu Relief

Overdose Warning (Overdose warning)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)

■ store at room temperature

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free: 1-888-333-9792

Principal Display Panel

When Using This Product (When using this product)

■ do not use more than directed

■ excitability may occur, especially in children

■ marked drowsiness may occur ■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ you get nervous, dizzy or sleepless

■ 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 rash or headache that lasts

These could be signs of a serious condition.

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

■ liver disease ■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

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

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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