Nite Time 501
fcd24753-b42b-4d05-8379-0ec0351ab217
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 cold/flu symptoms:
- sore throat
- minor aches and pain
- runny nose and sneezing
- cough due to minor sore throat and bronchial irritation
- headache
- fever
Section 55106-9
Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Warnings
Failure to follow these warnings could result in serious consequences
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 amoun
- 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 ccurs, 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 recommended-see Overdose warnings
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
- If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
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 sleepy
Product Label
Compare to VICKS® NYQUIL® active ingredients CVP CONSUMER VALUE PRODUCTS
Nite-Time COLD/FLU Medicine
Multi-Symptom ORIGINAL FLAVOR
Acetaminophen ..........................Aches, Fever and Sore Throat
Dextromethorphan ......................Cough
Doxylamine Succinate ................Sneezing, Runny nose
6 FL OZ (177 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil® LR-002
Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944
Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503 www.saladosales.com
LOT: EXP:
Peel Here DRUG FACTS CONTINUED ON BACK
ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine
- Antihistamine
- Cough Suppressant
- Pain Reliever
- Fever Reducer
res
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 dose cup contains:
- sodium 45 mg
- store at room temperature
Inactive Ingredients
citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
When Using This Product
- do not use more than directed
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Pregnant Or Breast Feeding
ask a health professional before use.
Stop Use and Ask A Doctor If
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
Keep Out of Reach of Children
Keep out of reach of children.
Ask A Doctor Before Use If You Have
- a sodium restricted diet
- 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
- if you are taking the blood thinning drug warfarin
Structured Label Content
Uses
temporarily relieves cold/flu symptoms:
- sore throat
- minor aches and pain
- runny nose and sneezing
- cough due to minor sore throat and bronchial irritation
- headache
- fever
Section 55106-9 (55106-9)
Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Warnings
Failure to follow these warnings could result in serious consequences
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 amoun
- 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 ccurs, 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 recommended-see Overdose warnings
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
- If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
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 sleepy
Product Label
Compare to VICKS® NYQUIL® active ingredients CVP CONSUMER VALUE PRODUCTS
Nite-Time COLD/FLU Medicine
Multi-Symptom ORIGINAL FLAVOR
Acetaminophen ..........................Aches, Fever and Sore Throat
Dextromethorphan ......................Cough
Doxylamine Succinate ................Sneezing, Runny nose
6 FL OZ (177 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil® LR-002
Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944
Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503 www.saladosales.com
LOT: EXP:
Peel Here DRUG FACTS CONTINUED ON BACK
ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine
- Antihistamine
- Cough Suppressant
- Pain Reliever
- Fever Reducer
res
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 dose cup contains:
- sodium 45 mg
- store at room temperature
Inactive Ingredients (Inactive ingredients)
citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
When Using This Product
- do not use more than directed
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Pregnant Or Breast Feeding (Pregnant Or Breast-Feeding)
ask a health professional before use.
Stop Use and Ask A Doctor If (Stop Use And Ask A Doctor If)
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
Keep Out of Reach of Children (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)
- a sodium restricted diet
- 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 (Ask A Doctor or Pharmacist before use)
- if you are taking sedatives or tranquilizers
- if you are taking the blood thinning drug warfarin
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:37.254007 · Updated: 2026-03-14T23:02:16.200124