Drug Facts

Drug Facts
SPL v14
SPL
SPL Set ID 15e9a336-1b34-4f00-9d1c-b945ddf17ed9
Route
ORAL
Published
Effective Date 2024-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg) Phenylephrine (10 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Lecithin, Soybean Light Mineral Oil Mannitol Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: PC9 Shape: oval Shape: capsule Color: green Color: orange Size: 21 mm Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-26
Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

DAYTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • nasal condition
    • headache
    • minor aches and pains
    • fever
    • sore throat

NIGHTTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose & sneezing
Warnings

DAYTIME NIGHTTIME

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole: do not crush, chew, or dissolve
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • children under 12 years: do not use

NIGHT TIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole: do not crush, chew, or dissolve
  • adult and children 12 years and over: take 2 softgels with water every 6 hours
  • children under 12 years: do not use
Do Not Use

DAYTIME NIGHTTIME

  • 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.
Product Label
READYinCASE Day Time Night Time Cold and Flu Relief
Other Information
  • store between 15°-30°C (59°-86°F)
  • avoid excessive heat
Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Inactive Ingredients

Daytime FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white  ink

Nighttime D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

when using daytime and nighttime products, carefully read the labeling to ensure correct dosing.

DAYTIME

non-drowsy

multi-symptom

day time

cold & flu relief

Acetaminophen 325 mg

dextromethorphan HBr 10 mg

phenylephrine HCl 5 mg

pain reliever/fever reducer

cough suppressant

nasal decongestant

alcohol-free

antihistamine-free

softgels**

(**liquid-filled capsules)

NIGHTTIME

Compare to the active ingredients in Vicks® DayQuil® and NyQuil®Cold & Flu LiquiCap®†

multi-symptom

night time

cold & flu relief

Acetaminophen 325 mg

dextromethorphan HBr 15 mg

doxylamine succinate 6.25 mg

pain reliever/fever reducer

cough suppressant

antihistamine

alcohol-free

softgels

(**liquid-filled capsules)

*This product is not manufactured or distributed by The Procter & Gamble Company, Vicks® DayQuil® and NyQuil® LiquiCaps® are registered trademarks of The Procter and Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

When Using This Product,

DAYTIME

do not use more than directed.

NIGHTTIME

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If

DAYTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

NIGHTTIME

  • 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

DAYTIME NIGHTTIME

Overdose warning: Taking more than the recommended dose can cause liver damage. 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

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occur with smoking, asthma, or emphysema

NIGHTTIME

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland 
Active Ingredients in Daytime (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

DAYTIME

  • taking the blood thinning drug warfarin.

NIGHTTIME

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Active Ingredients in Nighttime (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Structured Label Content

Uses

DAYTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • nasal condition
    • headache
    • minor aches and pains
    • fever
    • sore throat

NIGHTTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose & sneezing
Warnings

DAYTIME NIGHTTIME

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole: do not crush, chew, or dissolve
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • children under 12 years: do not use

NIGHT TIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole: do not crush, chew, or dissolve
  • adult and children 12 years and over: take 2 softgels with water every 6 hours
  • children under 12 years: do not use
Do Not Use (Do not use)

DAYTIME NIGHTTIME

  • 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.
Product Label
READYinCASE Day Time Night Time Cold and Flu Relief
Other Information (Other information)
  • store between 15°-30°C (59°-86°F)
  • avoid excessive heat
Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Inactive Ingredients (Inactive ingredients)

Daytime FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white  ink

Nighttime D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

when using daytime and nighttime products, carefully read the labeling to ensure correct dosing.

DAYTIME

non-drowsy

multi-symptom

day time

cold & flu relief

Acetaminophen 325 mg

dextromethorphan HBr 10 mg

phenylephrine HCl 5 mg

pain reliever/fever reducer

cough suppressant

nasal decongestant

alcohol-free

antihistamine-free

softgels**

(**liquid-filled capsules)

NIGHTTIME

Compare to the active ingredients in Vicks® DayQuil® and NyQuil®Cold & Flu LiquiCap®†

multi-symptom

night time

cold & flu relief

Acetaminophen 325 mg

dextromethorphan HBr 15 mg

doxylamine succinate 6.25 mg

pain reliever/fever reducer

cough suppressant

antihistamine

alcohol-free

softgels

(**liquid-filled capsules)

*This product is not manufactured or distributed by The Procter & Gamble Company, Vicks® DayQuil® and NyQuil® LiquiCaps® are registered trademarks of The Procter and Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

When Using This Product, (When using this product,)

DAYTIME

do not use more than directed.

NIGHTTIME

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

DAYTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

NIGHTTIME

  • 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

DAYTIME NIGHTTIME

Overdose warning: Taking more than the recommended dose can cause liver damage. 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

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occur with smoking, asthma, or emphysema

NIGHTTIME

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland 
Active Ingredients in Daytime (in Each Softgel) (Active ingredients in Daytime (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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

DAYTIME

  • taking the blood thinning drug warfarin.

NIGHTTIME

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Active Ingredients in Nighttime (in Each Softgel) (Active ingredients in Nighttime (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:09.464866 · Updated: 2026-03-14T23:03:02.507799