Day-time Cold & Flu Relief

Day-time Cold & Flu Relief
SPL v2
SPL
SPL Set ID c5f6cf22-2aaa-40e1-b7b3-448e55898d62
Route
ORAL
Published
Effective Date 2023-04-06
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
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Methylparaben Propylparaben Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SN2 Shape: capsule Color: orange Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-04

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
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 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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
  • heart disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

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

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

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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 4 hrs
 children 4 to under 12 yrs  ask a doctor
 children under 4 yrs  do not use

Package Label

NDC 69517-160-10

10 Softgels

Day-Time Cold & Flu Relief

Acetaminophen, Phenylephrine, Dextromethorphan

  • Aches, Fever & Sore Throat
  • Nasal Congestion
  • Cough

*Compare to the active ingredients in Vicks Dayquil ®

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 Dayquil ®

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

FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, methyl paraben, propyl paraben, titanium dioxide.

Questions Or Comments?

1-844-832-1138

M-F 9am-5pm EST

Active Ingredients (in Each Softgels)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Keep Out of Reach of Children. 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 & for children even if you do not notice any signs or symptoms.


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Section 42229-5 (42229-5)

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

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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
  • heart disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

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

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

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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 4 hrs
 children 4 to under 12 yrs  ask a doctor
 children under 4 yrs  do not use

Package Label (PACKAGE LABEL)

NDC 69517-160-10

10 Softgels

Day-Time Cold & Flu Relief

Acetaminophen, Phenylephrine, Dextromethorphan

  • Aches, Fever & Sore Throat
  • Nasal Congestion
  • Cough

*Compare to the active ingredients in Vicks Dayquil ®

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 Dayquil ®

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)

FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, methyl paraben, propyl paraben, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-844-832-1138

M-F 9am-5pm EST

Active Ingredients (in Each Softgels) (Active ingredients (in each Softgels))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Keep Out of Reach of Children. Overdose Warning: (Keep out of reach of children. 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 & for children even if you do not notice any signs or symptoms.


Advanced Ingredient Data


Raw Label Data

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