Skip to content

Checked

OTC

Nitetime

acetaminophen, dextromethorphan hbr, doxylamine succinate · Nitetime is an over-the-counter drug containing acetaminophen, dextromethorphan hbr, doxylamine succinate, made by Publix Super Markets Inc.

Type
Over the counter
Drug class
Not classified
Route
Oral
Manufacturers
1

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

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Active ingredients

(in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

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

Directions

  • Take only as directed - see Overdose warning
  • 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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • More than 4,000 mg of acetaminophen in 24 hours
  • 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. 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 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 Ask a doctor or pharmacist before use if you are
  • Taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin 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.

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

Ask a doctor before use

  • 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

Ask a doctor or pharmacist before use

  • Taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin

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

  • 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 breastfeeding

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.

Other information

  • Each 30 mL contains: sodium 35 mg
  • Store at 68-77 ° F (20-25 ° C)

Inactive ingredients

Alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Capsule, liquid filled325 mg / 15 mg / 6.25 mgoral1
Solution650 mg/30mL / 30 mg/30mL / 12.5 mg/30mLoral1

Manufacturers and labels

2 FDA labels

  • Publix Super Markets IncShown hereM012 · Label 05/06/2026 · NDC 56062-335Full label
  • Publix Super Markets IncM012 · Label 01/19/2026 · NDC 56062-056Full label

Nitetime: common questions

What is Nitetime used for?
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
Is Nitetime a prescription drug?
No. Nitetime is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Nitetime?
Yes. Other FDA-listed products with the same active ingredients include Nighttime Cold and Flu Relief, Nighttime Cold and Flu, Nighttime Cold and Flu, Cold and Flu.
Who makes Nitetime?
Publix Super Markets Inc lists Nitetime with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 05/06/2026 · Label text is shown as published by the manufacturer. Not medical advice