Daytime Severe Cold And Flu Capsule, Liquid Filled

Daytime Severe Cold And Flu Capsule, Liquid Filled
SPL v4
SPL
SPL Set ID cbd3a905-1c41-4cb0-8df6-36784430d627
Route
ORAL
Published
Effective Date 2019-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC26 Shape: capsule Color: orange Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-07-11

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/ fever reducer Cough suppressant  Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/ fever reducer

Cough suppressant 

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine Hydrochloride 5 mg

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 42228-7

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

Section 50565-1

Keep out of reach of children.

Warnings

Liver warning

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

  • more than 4 softgels 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

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 of age and over

2 softgels with water every 4 hours

children 4 to under 12 years of age

ask a doctor

children under 4 years of age

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.
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 and avoid excessive heat
Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

When Using This Product

do not use more than directed

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 Capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Principal Display Panel Shipping Label

DAYTIME SEVERE COLD AND FLU CAPSULES Quantity : 3000 Capsules

NDC. No : 53345-021-01 IMPORTANT: Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Ask A Doctor Or Pharmacist Before Use If You Are

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 42228-7 (42228-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

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 softgels 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

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 of age and over

2 softgels with water every 4 hours

children 4 to under 12 years of age

ask a doctor

children under 4 years of age

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.
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 and avoid excessive heat
Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

When Using This Product (When using this product)

do not use more than directed

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 Capsule) (Active ingredients (in each capsule))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

DAYTIME SEVERE COLD AND FLU CAPSULES Quantity : 3000 Capsules

NDC. No : 53345-021-01 IMPORTANT: Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

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

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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