Daytime Cold And Flu Capsules (pe Free)

Daytime Cold And Flu Capsules (pe Free)
SPL v1
SPL
SPL Set ID 46996bbf-948c-0aba-e063-6394a90a09e3
Route
ORAL
Published
Effective Date 2025-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg)
Inactive Ingredients
Glycerin Gelatin Type B Bovine (150 Bloom) Polyethylene Glycol 400 Water Sorbitol Povidone K12 Sorbitan Propylene Glycol Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: P41 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-28

Description

Drug Facts

Purpose

Pain Reliever/Fever Reducer Cough Suppressant


Medication Information

Purpose

Pain Reliever/Fever Reducer

Cough Suppressant

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

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

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose.

Section 53414-9

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

Directions
  • Take only as directed (see overdose warning)
  • Do not take more than 4 doses in 24 hours.
adults and children 12 years and over 2 softgels with water every 4 hours
children 4 to under 12 years consult a doctor
children under 4 years 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
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

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 every day while using this product
Overdose Warning

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Prompt 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 15° - 30 °C (59°- 86 °F)
  • Read all product information before using.
  • Tamper evident: Do not use if carton is open or blister unit is broken.
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.

Inactive Ingredients

FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White ink.

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Daytime Cold and Flu Capsules (PE free)

Each softgel contains: Acetaminophen 325mg/ Dextromethorphan HBr 10mg

NDC 53345-056-01

Caution: for further manufacturing, processing or repackaing

Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts 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
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose.

Section 53414-9 (53414-9)

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

Purpose

Pain Reliever/Fever Reducer

Cough Suppressant

Directions
  • Take only as directed (see overdose warning)
  • Do not take more than 4 doses in 24 hours.
adults and children 12 years and over 2 softgels with water every 4 hours
children 4 to under 12 years consult a doctor
children under 4 years do not use
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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert (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

Liver Warning (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 every day while using this product
Overdose Warning (Overdose warning)

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Prompt 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 15° - 30 °C (59°- 86 °F)
  • Read all product information before using.
  • Tamper evident: Do not use if carton is open or blister unit is broken.
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White ink.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call toll free: 1-855-215-8180

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Daytime Cold and Flu Capsules (PE free)

Each softgel contains: Acetaminophen 325mg/ Dextromethorphan HBr 10mg

NDC 53345-056-01

Caution: for further manufacturing, processing or repackaing

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts 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)
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Active Ingredients (in Each Softgel) (Active Ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg


Advanced Ingredient Data


Raw Label Data

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