417 - Daytime Cold And Flu Relief

417 - Daytime Cold And Flu Relief
SPL v3
SPL
SPL Set ID d592fbb8-d4bf-444e-982e-edf6fe97dce4
Route
ORAL
Published
Effective Date 2023-10-31
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, Unspecified Povidone Propylene Glycol Water Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Imprint: PC9 Shape: capsule Color: orange Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-03

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Use(s)
  • temporarily relieves common cold/flu symptoms:
  • • nasal congestion
  • • cough due to minor throat & bronchial irritation
  • • sore throat
  • • headache
  • • minor aches & pains
  • • fever
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 every day 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, persists for more than 2 days,

occurs with or is followed by fever, headache, rash, nausea, or vomiting,

consult a doctor promptly.

Directions
  • Take only as directed
  •  Do not exceed 4 doses in 24 hours   

adults and children 12 years & over: 2 softgels with water every 4 hours

children 4 to under 12 years: ask 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 drugs. 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 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Inactive Ingredients

FD&C red #40, FD&C yellow #6,

gelatin, glycerin, polyethylene glycol, povidone, propylene

glycol, purified water, sorbitol sorbitan solution, white edible ink

Principal Display Panel
Daytime Cold and Flu
When Using This Product

do not use more than directed

Ask A Doctor Before Use If

• liver disease • heart disease • thyroid disease • diabetes • high blood pressure

• trouble urinating due to an enlarged prostate gland • cough that occurs

with too much phlegm (mucus) • persistent or chronic cough as occurs

with smoking, asthma, or emphysema

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.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

Taking more than directed can cause serious health problems. In case of

overdose, get medical help or contact a Poison Control Center

(1-800-222-1222) right away. Quick medical attention is

critical for adults as well as for children, even if you do not

notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use If

taking the blood thinning drug warfarin.


Structured Label Content

Use(s)
  • temporarily relieves common cold/flu symptoms:
  • • nasal congestion
  • • cough due to minor throat & bronchial irritation
  • • sore throat
  • • headache
  • • minor aches & pains
  • • fever
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 every day 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, persists for more than 2 days,

occurs with or is followed by fever, headache, rash, nausea, or vomiting,

consult a doctor promptly.

Directions
  • Take only as directed
  •  Do not exceed 4 doses in 24 hours   

adults and children 12 years & over: 2 softgels with water every 4 hours

children 4 to under 12 years: ask 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 drugs. If you do not know if your

    prescription drug contains an MAOI, ask a doctor or pharmacist

    before taking this product.
Other Information (Other information)
  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6,

gelatin, glycerin, polyethylene glycol, povidone, propylene

glycol, purified water, sorbitol sorbitan solution, white edible ink

Principal Display Panel
Daytime Cold and Flu
When Using This Product (When using this product)

do not use more than directed

Ask A Doctor Before Use If (Ask a doctor before use if)

• liver disease • heart disease • thyroid disease • diabetes • high blood pressure

• trouble urinating due to an enlarged prostate gland • cough that occurs

with too much phlegm (mucus) • persistent or chronic cough as occurs

with smoking, asthma, or emphysema

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.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Taking more than directed can cause serious health problems. In case of

overdose, get medical help or contact a Poison Control Center

(1-800-222-1222) right away. Quick medical attention is

critical for adults as well as for children, even if you do not

notice any signs or symptoms.

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

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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