Cvs Nighttime Cold & Flu Relief Drug Facts
87d4cfc0-c7b4-42c0-bfa9-96e124e32ed3
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Description
Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
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
Warnings
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
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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Other Information
- each 30 mL contains:sodium 16 mg
- store at room temperature and do not refrigerate
Inactive Ingredients
anhydrous citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No. 3, FD & C Yellow No 6, flavors, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose.
Questions Or Comments?
1-866-467-2748
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.
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.
Active Ingredients (in Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Package/label Principal Display Panel
Compare to the active ingredients in VICKS ®Nyquil™ Cold & Flu*
NDC 51316-692-12
Nighttime Cold & Flue Relief
Acetaminophen,Dextromethorphan succinate,
Doxylamine HBr
Headache, Fever, Sore Throat
Minor Aches & Pains
Sneezing, Runny Nose, Cough
Original Flavor
12 FL OZ (354 mL)
Distributed by:
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks ®Nyquil™ Cold & Flu*
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
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Warnings
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
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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
- each 30 mL contains:sodium 16 mg
- store at room temperature and do not refrigerate
Inactive Ingredients (Inactive ingredients)
anhydrous citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No. 3, FD & C Yellow No 6, flavors, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose.
Questions Or Comments? (Questions or comments?)
1-866-467-2748
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.
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.)
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.
Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
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 such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Compare to the active ingredients in VICKS ®Nyquil™ Cold & Flu*
NDC 51316-692-12
Nighttime Cold & Flue Relief
Acetaminophen,Dextromethorphan succinate,
Doxylamine HBr
Headache, Fever, Sore Throat
Minor Aches & Pains
Sneezing, Runny Nose, Cough
Original Flavor
12 FL OZ (354 mL)
Distributed by:
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks ®Nyquil™ Cold & Flu*
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
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:34.074688 · Updated: 2026-03-14T23:11:10.262850