Dolgencorp, Llc Cold & Flu Relief Drug Facts

SPL v7

SPL

SPL Set ID ff4a2f0a-d638-4ed2-8e05-2a52afbc4909

Route

ORAL

Published

Effective Date 2025-12-09

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, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: L994 Shape: oval Color: orange Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2009-10-02 Until 2024-10-31

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

temporarily relieves common cold/flu symptoms:

•
cough due to minor throat and bronchial irritation
•
minor aches and pains
•
nasal congestion
•
sore throat
•
headache
•
fever

Warnings

Liver warning: This product contains 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

•
take only as directed – see overdose warning
•
do not exceed 4 doses per 24 hrs

adults & 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

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

Other Information

•
store at 20-25°C (68-77°F)

Inactive Ingredients

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions Or Comments?

1-888-309-9030

Principal Display Panel

DG^™|health

Compare to active ingredients of Vicks^® DayQuil^® Cold & Flu

Day Time

Cold & Flu Relief

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

Multi-Symptom Relief of:

• Aches, Fever, Sore Throat

• Nasal Congestion

• Cough

Non-Drowsy

• Alcohol free • Antihistamine free

24 Softgels

Actual Softgel Size

When Using This Product

do not use more than directed

Stop Use and Ask A Doctor If

•
you get nervous, dizzy or sleepless
•
pain, nasal congestion 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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

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

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

•
cough due to minor throat and bronchial irritation
•
minor aches and pains
•
nasal congestion
•
sore throat
•
headache
•
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 4,000 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

•
take only as directed – see overdose warning
•
do not exceed 4 doses per 24 hrs

adults & 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

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

Other Information (Other information)

•
store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions Or Comments? (Questions or comments?)

1-888-309-9030

Principal Display Panel

DG^™|health

Compare to active ingredients of Vicks^® DayQuil^® Cold & Flu

Day Time

Cold & Flu Relief

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

Multi-Symptom Relief of:

• Aches, Fever, Sore Throat

• Nasal Congestion

• Cough

Non-Drowsy

• Alcohol free • Antihistamine free

24 Softgels

Actual Softgel Size

When Using This Product (When using this product)

do not use more than directed

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

•
you get nervous, dizzy or sleepless
•
pain, nasal congestion 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.)

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

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

Active Ingredients (in Each Softgel) (Active ingredients (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)

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • minor aches and pains • nasal congestion • sore throat • headache • 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 4,000 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Directions": "• take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs adults & 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", "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", "Other information": "• store at 20-25°C (68-77°F)", "Inactive ingredients": "edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient", "Questions or comments?": "1-888-309-9030", "Principal Display Panel": "DG ™ |health Compare to active ingredients of Vicks ® DayQuil ® Cold & Flu Day Time Cold & Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant Multi-Symptom Relief of: • Aches, Fever, Sore Throat • Nasal Congestion • Cough Non-Drowsy • Alcohol free • Antihistamine free 24 Softgels Actual Softgel Size", "When using this product": "do not use more than directed", "Stop use and ask a doctor if": "• you get nervous, dizzy or sleepless • pain, nasal congestion 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.": "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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": "• cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema • trouble urinating due to an enlarged prostate gland • liver disease • heart disease • high blood pressure • thyroid disease • diabetes", "Active ingredients (in each softgel)": "Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:35.448834 · Updated: 2026-03-14T23:11:11.874697