Daytime Cold And Flu Capsule, Liquid Filled (acetaminophen 325mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)

Daytime Cold And Flu Capsule, Liquid Filled (acetaminophen 325mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)
SPL v2
SPL
SPL Set ID 841dcd0c-381c-4041-aae7-5609573e82d2
Route
ORAL
Published
Effective Date 2021-02-28
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
Polyethylene Glycol 400 Propylene Glycol Povidone K30 Fd&c Red No. 40 Fd&c Yellow No. 6 Titanium Dioxide Gelatin Glycerin Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-03-01

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg


Medication Information

Warnings and Precautions

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • nasal congestion
  • sore throat
  • headache
  • minor aches/pains
  • fever
Purose
  • Pain reliever/ fever reducer
  • Cough suppressant
  • Nasal decongestant
Directions
  • take only as recommended - see OVERDOSE warning
  • do not exceed 6 doses per 24 hours
Adults and children 12 years of age and older 2 LiquiCaps with water every 4 hours
Children under 12 years of age ask doctor

When using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Do Not Use
  • with other medicines containing acetaminophen
  • 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.
Other Information
  • store at room temperature 59°-86°F (15°-30°C)
Inactive Ingredients

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

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.

Ask A Doctor Before Use If You Have
  • heart disease
  • thyroid 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, or emphysema
Active Ingredients (in Each Capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Principal Display Panel Shipping Label

Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules

Each Softgel Contains:

(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg,

Phenylephrine Hydrochloride USP 5mg)

LOT NO:

DRUM NO:

MFG DATE:

QUANTITY:

NDC NO: 55629-012-

EXP DATE:

WARNING:

KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.



CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH

THE F.D & C.ACT AND REGULATIONS THEREUNDER.


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • nasal congestion
  • sore throat
  • headache
  • minor aches/pains
  • fever
Purose
  • Pain reliever/ fever reducer
  • Cough suppressant
  • Nasal decongestant
Warnings and Precautions (34071-1)

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • take only as recommended - see OVERDOSE warning
  • do not exceed 6 doses per 24 hours
Adults and children 12 years of age and older 2 LiquiCaps with water every 4 hours
Children under 12 years of age ask doctor

When using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Do Not Use
  • with other medicines containing acetaminophen
  • 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.
Other Information
  • store at room temperature 59°-86°F (15°-30°C)
Inactive Ingredients (Inactive ingredients)

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • thyroid 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, or emphysema
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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

Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules

Each Softgel Contains:

(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg,

Phenylephrine Hydrochloride USP 5mg)

LOT NO:

DRUM NO:

MFG DATE:

QUANTITY:

NDC NO: 55629-012-

EXP DATE:

WARNING:

KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.



CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH

THE F.D & C.ACT AND REGULATIONS THEREUNDER.


Advanced Ingredient Data


Raw Label Data

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