438 - Daytime Nighttime Cold And Flu

438 - Daytime Nighttime Cold And Flu
SPL v6
SPL
SPL Set ID fa7ed5db-4da7-46b4-a08d-1d79cb7a5674
Route
ORAL
Published
Effective Date 2022-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Solution D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: PC10 Shape: capsule Color: orange Color: green Size: 21 mm Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-20
Description

DAYTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg NIGHTTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg

Purpose

DAYTIME ONLY Pain reliever/fever reducer Cough suppressant Nasal decongestant   NIGHTTIME ONLY Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

DAYTIME ONLY

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

 

NIGHTTIME ONLY

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

DAYTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg NIGHTTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg

Use(s)

DAYTIME ONLY

temporarily relieves common cold/flu symptoms: • nasal

congestion • cough due to minor throat & bronchial irritation • sore

throat • headache • minor aches & pains • fever

NIGHTTIME ONLY

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation • sore throat • headache

• minor aches & pains • fever • runny nose & sneezing

Warnings

DAYTIME AND NIGHTTIME

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.

Questions

Questions or comments?

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

Directions

DAYTIME ONLY

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

adults and 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

 

NIGHTTIME ONLY

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

adults and children 12 yrs & over: 2 softgels with water every 6 hrs

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use



Do Not Use

DAYTIME ONLY

• 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.

NIGHTTIME ONLY

• 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.

• to make a child sleep

Other Information
  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open

Active Ingredient(s)

DAYTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

NIGHTTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Inactive Ingredients

DAYTIME ONLY

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene

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

 

NIGHTTIME ONLY

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene

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

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel
Daytime and Nighttime
When Using This Product

DAYTIME ONLY

do not use more than directed

 

NIGHTTIME ONLY

• do not use more than directed

 • excitability may occur, especially in children

• marked drowsiness may occur • avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives & tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

DAYTIME ONLY

• 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.

 

NIGHTTIME ONLY

• pain 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.

Keep Out of Reach of Children

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 Before Use If You Have

DAYTIME ONLY

• 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

NIGHTTIME ONLY

• liver disease •glaucoma • cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking,

  asthma, chronic bronchitis or emphysema

• trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If

DAYTIME ONLY

taking the blood thinning drug warfarin.

 

NIGHTTIME ONLY

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Structured Label Content

Use(s)

DAYTIME ONLY

temporarily relieves common cold/flu symptoms: • nasal

congestion • cough due to minor throat & bronchial irritation • sore

throat • headache • minor aches & pains • fever

NIGHTTIME ONLY

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation • sore throat • headache

• minor aches & pains • fever • runny nose & sneezing

Purpose

DAYTIME ONLY

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

 

NIGHTTIME ONLY

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Warnings

DAYTIME AND NIGHTTIME

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.

Questions

Questions or comments?

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

Directions

DAYTIME ONLY

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

adults and 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

 

NIGHTTIME ONLY

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

adults and children 12 yrs & over: 2 softgels with water every 6 hrs

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use



Do Not Use (Do not use)

DAYTIME ONLY

• 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.

NIGHTTIME ONLY

• 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.

• to make a child sleep

Other Information (Other information)
  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open

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

DAYTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

NIGHTTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Inactive Ingredients (Inactive ingredients)

DAYTIME ONLY

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene

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

 

NIGHTTIME ONLY

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene

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

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

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

DAYTIME ONLY

do not use more than directed

 

NIGHTTIME ONLY

• do not use more than directed

 • excitability may occur, especially in children

• marked drowsiness may occur • avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives & tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

DAYTIME ONLY

• 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.

 

NIGHTTIME ONLY

• pain 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.

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

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 Before Use If You Have (Ask a doctor before use if you have)

DAYTIME ONLY

• 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

NIGHTTIME ONLY

• liver disease •glaucoma • cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking,

  asthma, chronic bronchitis or emphysema

• trouble urinating due to enlarged prostate gland

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

DAYTIME ONLY

taking the blood thinning drug warfarin.

 

NIGHTTIME ONLY

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:04.836449 · Updated: 2026-03-14T23:10:16.319664