Nite Time Cold and Flu Relief
Capsule, Liquid Filled · Oral
Active ingredient
Active ingredient(s) Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
Uses
Use(s) temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 Ask a doctor before use if
• 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
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin 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 when driving a motor vehicle or operating machinery
• alcohol, sedatives & 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 breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
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
Ask a doctor before use
Ask a doctor before use if
• 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
Ask a doctor or pharmacist before use if
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
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 when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness
Stop use and ask a doctor
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.
Pregnancy or breast-feeding
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
Directions take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 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
Inactive ingredients
Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink
Questions?
Questions/Comments Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Label text from the FDA structured product label by TopCo Associates, LLC (revised Oct 31, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Dextromethorphan Hydrobromide in 1 product
- Doxylamine Succinate in 1 product
Nite Time Cold and Flu Relief NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 76162-026 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled | TopCo Associates, LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Nite Time Cold and Flu Relief used for?
Use(s) temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing
Who makes Nite Time Cold and Flu Relief?
Nite Time Cold and Flu Relief is listed by 1 labeler in the FDA NDC directory, including TopCo Associates, LLC.