Night-time Cold & Flu Relief

Night-time Cold & Flu Relief
SPL v2
SPL
SPL Set ID 2ffd62a6-703f-4cb0-bb13-49719c004d00
Route
ORAL
Published
Effective Date 2023-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Blue No. 1 D&c Yellow No. 10 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Methylparaben Propylparaben Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SN3 Shape: capsule Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-04

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Section 42229-5

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

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 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

Ask a doctor before use if you have

  • liver disease
  • 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 use if you are

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

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain 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.

Direction
  • take only as directed
  • do not exceed 4 doses per 24 hours
 adults & children 12 yrs & over  2 softgels with water every 6 hrs
 children 4 to under 12 yrs  ask a doctor
 children under 4 yrs  do not use

Package Label

NDC 69517-161-10

10 Softgels

Night-Time Cold & Flu Relief

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Sneezing, Runny Nose
  • Cough

*Compare to the active ingredients in Vicks Nyquil ®

Distributed By:

Health life of USA LLC

Rahway, NJ 07065

www.healthlifeus.com

*This product is not manufactured or distributed by Procter & Gamble, Distributor of Vicks Nyquil ®

Other Information
  • store at room temperature.
  • TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
  • KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Inactive Ingredients

D&C Yellow No.10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, methyl paraben, propyl paraben.

Questions Or Comments?

1-844-832-1138

M-F 9am-5pm EST

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 Softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Section 42229-5 (42229-5)

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

Purpose

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

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 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

Ask a doctor before use if you have

  • liver disease
  • 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 use if you are

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

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain 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.

Direction
  • take only as directed
  • do not exceed 4 doses per 24 hours
 adults & children 12 yrs & over  2 softgels with water every 6 hrs
 children 4 to under 12 yrs  ask a doctor
 children under 4 yrs  do not use

Package Label (PACKAGE LABEL)

NDC 69517-161-10

10 Softgels

Night-Time Cold & Flu Relief

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Sneezing, Runny Nose
  • Cough

*Compare to the active ingredients in Vicks Nyquil ®

Distributed By: (Distributed by:)

Health life of USA LLC

Rahway, NJ 07065

www.healthlifeus.com

*This product is not manufactured or distributed by Procter & Gamble, Distributor of Vicks Nyquil ®

Other Information (Other information)
  • store at room temperature.
  • TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
  • KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Inactive Ingredients (Inactive ingredients)

D&C Yellow No.10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, methyl paraben, propyl paraben.

Questions Or Comments? (Questions or comments?)

1-844-832-1138

M-F 9am-5pm EST

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 Softgels) (Active ingredients (in each Softgels))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Advanced Ingredient Data


Raw Label Data

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