Nighttime Relief Cold & Flu Relief

SPL v1

SPL

SPL Set ID 3b4610e3-367d-4b5b-9b3d-761aecd7899c

Route

ORAL

Published

Effective Date 2020-10-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-09-21

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 and pains
•
fever
•
runny nose and sneezing

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 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.

Section 53414-9

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

Section 55105-1

Active ingredients (in each 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

Directions

•
take only as directed
•
only use the dose cup provided
•
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 6 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.
▪
to make a child sleep

Questions?

1-800-467-2748

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

•
each 30 mL contains: sodium 16 mg
•
store at room temperature and do not refrigerate

Sore Throat Warning

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

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose, xanthan gum

When Using This Product

▪
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, 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
▪
a sodium-restricted diet

Principal Display Panel 236 Ml Bottle Label

Compare to the active ingredients in Vicks^®NyQuil™ Cold & Flu Nighttime Relief*

NDC# 30142-629-12

Nighttime Cold & Flu Relief

Acetaminophen, Doxylamine,

Dextromethorphan HBr

•
Headaches, Fever & Sore Throat
•
Minor Aches & Pains
•
Sneezing, Runny Nose
•
Cough

Natural Cherry Flavor

12 FL. OZ. (354 mL)

Distributed by:

*This product is not manufacturing or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ Cold & Flu Nighttime Relief.

Ask A Doctor Or Pharmacist Before Use If You Are

▪
taking sedatives or tranquilizers
▪
taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

•
cough due to minor throat and bronchial irritation
•
sore throat
•
headache
•
minor aches and 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 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

Directions

•
take only as directed
•
only use the dose cup provided
•
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL 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)

▪
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

Questions?

1-800-467-2748

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)

•
each 30 mL contains: sodium 16 mg
•
store at room temperature and do not refrigerate

Sore Throat Warning (Sore throat warning)

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

Inactive Ingredients (Inactive ingredients)

When Using This Product (When using this product)

▪
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, 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
▪
a sodium-restricted diet

Principal Display Panel 236 Ml Bottle Label (Principal Display Panel - 236 ml Bottle Label)

Compare to the active ingredients in Vicks^®NyQuil™ Cold & Flu Nighttime Relief*

NDC# 30142-629-12

Nighttime Cold & Flu Relief

Acetaminophen, Doxylamine,

Dextromethorphan HBr

•
Headaches, Fever & Sore Throat
•
Minor Aches & Pains
•
Sneezing, Runny Nose
•
Cough

Natural Cherry Flavor

12 FL. OZ. (354 mL)

Distributed by:

*This product is not manufacturing or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ Cold & Flu Nighttime Relief.

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

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 and pains • fever • runny nose and sneezing", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 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.", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine", "Directions": "• take only as directed • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 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. ▪ to make a child sleep", "Questions?": "1-800-467-2748", "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": "• each 30 mL contains: sodium 16 mg • store at room temperature and do not refrigerate", "Sore throat warning": "If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.", "Inactive ingredients": "anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose, xanthan gum", "When using this product": "▪ 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, 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 ▪ a sodium-restricted diet", "Principal Display Panel - 236 ml Bottle Label": "Compare to the active ingredients in Vicks ® NyQuil™ Cold & Flu Nighttime Relief* NDC# 30142-629-12 Nighttime Cold & Flu Relief Acetaminophen, Doxylamine, Dextromethorphan HBr • Headaches, Fever & Sore Throat • Minor Aches & Pains • Sneezing, Runny Nose • Cough Natural Cherry Flavor 12 FL. OZ. (354 mL) Distributed by: * This product is not manufacturing or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ Cold & Flu Nighttime Relief.", "Ask a doctor or pharmacist before use if you are": "▪ taking sedatives or tranquilizers ▪ taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:51.537339 · Updated: 2026-03-14T22:58:38.353182