Nighttime description, usages, side effects, indications, overdosage, supplying and lots more!

Nighttime

Taro Pharmaceuticals U.S.A. Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Nighttime Flu and Severe

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant

Uses

  • temporarily relieves:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

Liver warning

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

  • more than 6 packets 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

  • in a child under 4 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription).
    If you are not sure whether a drug contains acetaminophen, as a doctor or a pharmacist.
  • with any other product containing diphenhydramine, even one used on the skin
  • 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a sodium-restricted diet
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema, asthma or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are taking

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • symptoms do not get better or worsen
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a heath care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed
  • take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
  • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

Other information

  • each packet contains: potassium 4 mg, sodium 27 mg
  • phenylketonurics: contains phenylalanine 34 mg per packet
  • store at controlled room temperature 20°-25°C (68°-77°F). Protect from excessive heat and moisture.

Inactive ingredients

acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue No. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

Questions or Comments?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NDC 51672-2113-7

Compare to the active
ingredient in Theraflu
®
Nighttime Severe Cold & Cough*

See New Warnings
Information

Nighttime

Flu & Severe
Cold & Cough

Acetaminophen - Pain reliever/fever reducer
Diphenhydramine HCl - Antihistamine/cough suppressant
Phenylephrine HCl - Nasal decongestant


  • Nasal Congestion
  • Cough
  • Runny Nose
  • Sneezing
  • Body Ache
  • Sore Throat Pain
  • Headache
  • Fever

Honey Lemon
Infused with
Chamomile & White Tea Flavors

6 Packets

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

Nighttime

Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51672-2113
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ASPARTAME
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
maltodextrin
ANHYDROUS TRISODIUM CITRATE
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51672-2113-7 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-06-28


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Be sure to consult your doctor before taking any medication!
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