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Nitetime D

Meijer Distribution Inc

Meijer NiteTime D Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Pseudoephedrine HCl 30 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Nitetime D Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • 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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.
  • to make a child sleepy

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • 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
  • cough that lasts or is chronic as occurs with smoking, asthma or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • 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 and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • 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.

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.

Directions

  • take only as recommended – see Liver warning
  • use dose cup
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Nitetime D Other information

  • each TBSP contains: sodium 18 mg
  • store at 20°-25°C (68°-77°F)

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

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

Night Time D

Multi-Symptom Cold/Flu Relief

Relieves Cold and Flu-Like Symptoms So You Can Rest

Aches/Fever/Cough/Sneezing/Runny Nose

Nasal Congestion

with Pseudoephedrine

Pain Reliever/Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Antihistamine - Doxylamine succinate

Nasal Decongestant - Pseudoephedrine HCl

Original Flavor

Alcohol 10%

Compare to Vicks® NyQuil® D Cold & Flu active ingredients

Nitetime D
NiteTime D Label

Nitetime D

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-609
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Product Characteristics

Color
GREEN (Bright Green)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41250-609-38 296 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1994-02-01


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Be sure to consult your doctor before taking any medication!
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