nyquil severe cold & flu

nyquil severe cold & flu
SPL v1
SPL
SPL Set ID 8de6c330-fae4-438c-e053-2a95a90ab640
Route
oral
Published
Effective Date 2019-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) doxylamine (6.25 mg) phenylephrine (5 mg)
Inactive Ingredients
fd&c blue no. 2 crospovidone food yellow 3 free acid fd&c blue no. 1 d&c yellow no. 10 magnesium stearate silicon dioxide cellulose, microcrystalline polyethylene glycol, unspecified polyvinyl alcohol povidone stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: NQ Shape: oval Color: green Size: 1 mm Score: 1
Marketing Status
otc monograph final active Since 2019-07-08

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCL 5 mg


Medication Information

Warnings

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

• more than 8 caplets 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 ues 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 common cold/flu symptoms:

• nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation

• cough to help you sleep • minor aches & pains • headache

• fever • sore throat • runny nose & sneezing

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Directions

•take only as directed • do not exceed 8 caplets per 24 hrs

adults & children 12 yrs & over 2 caplets with water every 4 hrs

children 4 to under 12 yrs ask a doctor

children under 4 yrs do not use

Other Information

• do not exceed 25ºC

Inactive Ingredients

crospovidone, D&C Yellow No.10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCL 5 mg

Questions?

1-800-362-1683

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

Package Label

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 wore 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCL 5 mg

Ask A Doctor Before Use If You Have

• liver disease • heart disease • high blood pressure • thyroid disease

• diabetes • glaucoma • cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Ues If You Are

• taking sedatives or tranquilizers • taking the blood thinning drug warfarin


Structured Label Content

Warnings

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

• more than 8 caplets 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 ues 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 common cold/flu symptoms:

• nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation

• cough to help you sleep • minor aches & pains • headache

• fever • sore throat • runny nose & sneezing

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Directions

•take only as directed • do not exceed 8 caplets per 24 hrs

adults & children 12 yrs & over 2 caplets with water every 4 hrs

children 4 to under 12 yrs ask a doctor

children under 4 yrs do not use

Other Information

• do not exceed 25ºC

Inactive Ingredients (Inactive ingredients)

crospovidone, D&C Yellow No.10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

1-800-362-1683

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

Package Label

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 wore 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.

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

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCL 5 mg

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 • glaucoma • cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

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

• taking sedatives or tranquilizers • taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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