Acetaminophen Dextromethorphan Hbr & Doxylamine Succinate Softgel Capsules

SPL v2

SPL

SPL Set ID 1d600327-95c1-4512-b32a-430f619df1ac

Route

ORAL

Published

Effective Date 2014-11-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)

Inactive Ingredients

Polyethylene Glycol 400 Propylene Glycol Povidone K30 Water Gelatin Glycerin D&c Yellow No. 10 Fd&c Blue No. 1 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 215 Shape: oval Color: green Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-12-01

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat and bronchial irritation
sore throat
headache
minor aches/pains
fever
runny nose and sneezing

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1

Active ingredients (in each softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mg	Cough suppressant
Doxylamine Succinate 6.25 mg	Antihistamine

Directions

Take only as recommended—see Overdose warning.
do not exceed 4 doses per 24 hours

adults and children 12 years of age and over	swallow 2 softgels with water every 6 hours
children 4 to under 12 years of age	ask a doctor
children under 4 years of age	do not use

If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

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.
to make a child sleep

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

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 room temperature 15°-30°C (59°-86°F) and avoid excessive heat
this product does not contain phenylpropanolamine

Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

When Using This Product

do not use more than directed
excitability may occur especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful with driving a motor vehicle or operating machinery
alcohol, sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

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

Ask A Doctor Before Use If You Have

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 You Are

taking sedatives or tranquilizers
taking the blood-thinning drug warfarin.

Principal Display Panel 10 Softgel Blister Pack Carton

VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients

in VICKS ^® NyQUIL ^®*

MULTI-SYMPTOM

NITE TIME

COLD & FLU NIGHTTIME RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE

Pain Reliever
Fever Reducer
Cough Suppressant
Antihistamine

10 SOFTGELS

Liquid filled capsules

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat and bronchial irritation
sore throat
headache
minor aches/pains
fever
runny nose and sneezing

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mg	Cough suppressant
Doxylamine Succinate 6.25 mg	Antihistamine

Directions

Take only as recommended—see Overdose warning.
do not exceed 4 doses per 24 hours

adults and children 12 years of age and over	swallow 2 softgels with water every 6 hours
children 4 to under 12 years of age	ask a doctor
children under 4 years of age	do not use

If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

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.
to make a child sleep

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)

Other Information (Other information)

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
this product does not contain phenylpropanolamine

Sore Throat Warning (Sore throat warning)

If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Inactive Ingredients (Inactive ingredients)

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

When Using This Product (When using this product)

do not use more than directed
excitability may occur especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful with driving a motor vehicle or operating machinery
alcohol, sedatives and tranquilizers may increase drowsiness

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

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

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

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 You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers
taking the blood-thinning drug warfarin.

Principal Display Panel 10 Softgel Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton)

VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients

in VICKS ^® NyQUIL ^®*

MULTI-SYMPTOM

NITE TIME

COLD & FLU NIGHTTIME RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE

Pain Reliever
Fever Reducer
Cough Suppressant
Antihistamine

10 SOFTGELS

Liquid filled capsules

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 sore throat headache minor aches/pains fever runny nose and sneezing", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan Hydrobromide 15 mg Cough suppressant Doxylamine Succinate 6.25 mg Antihistamine", "Directions": "Take only as recommended—see Overdose warning . do not exceed 4 doses per 24 hours adults and children 12 years of age and over swallow 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing", "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. to make a child sleep", "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": "Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine", "Sore throat warning": "If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.", "Inactive ingredients": "D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide", "Questions or comments?": "1-888-333-9792", "When using this product": "do not use more than directed excitability may occur especially in children marked drowsiness may occur avoid alcoholic drinks be careful with driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "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", "Ask a doctor before use if you have": "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 you are": "taking sedatives or tranquilizers taking the blood-thinning drug warfarin.", "PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton": "VALUMEDS SEE NEW WARNINGS INFORMATION Compare to the active ingredients in VICKS ® NyQUIL ® * MULTI-SYMPTOM NITE TIME COLD & FLU NIGHTTIME RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE Pain Reliever Fever Reducer Cough Suppressant Antihistamine 10 SOFTGELS Liquid filled capsules"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:58.825012 · Updated: 2026-03-14T22:55:47.133560