Night time sinus description, usages, side effects, indications, overdosage, supplying and lots more!

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Night time sinus

Chain Drug Consortium, LLC (Premier Value)

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/ fever reducer

Antihistamine

Nasal decongestant

Night time sinus Uses

temporarily relieves nasal & sinus symptoms:

  • sinus pain
  • nasal & sinus congestion
  • headache
  • runny nose and sneezing

Warnings

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

  • more than 6 doses in 24 hrs, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly

Overdose warning: Taking more than directed can cause serious health problems.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults and 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • difficulty in urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives & 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

  • redness or swelling is present
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • symptoms do not get better within 7 days or are accompanied by a fever. 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.

Directions

  • take every 4 hours
  • do not take more than 6 doses in 24 hours
  • do not use more than directed (see Overdose warning)
  • when using other night- time and day- time products, carefully read each label to ensure correct dosing
 adults and children 12 years of age and older  swallow 2 softgels with water
 children 4 to 12 years of age  ask a doctor
 children under 4 years of age  do not use

Night time sinus Other information

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • this product does not contain penylpropanolamine (PPA)
  • *this product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Sinus

Inactive ingredients

bone gelatin, FD&C Blue No. 1, glycerin USP, polyethylene glycol 400 NF, povidone K12PF, propylene glycol USP, purified water, sorbitol special, and white edible ink.

Principal Display Panel

Multi- Symptom

Night- Time sinus Liquid capsules

Relieves:

Sinus headache

pain

congestion

Acetaminophen, Doxylamine succinate, Phenylephrine HCl

Pain reliever/ fever reducer, antihistamine, nasal decongestant

Distributed by:

Chain Drug Consortium, LLC

2300 NW Corporate blvd., suite 115

Boca Raton, FL 33431

Call toll free 1-877-753-3935

SEE NEW WARNINGS INFORMATION

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

PRINCIPAL DISPLAY PANEL - 24 Capsule Carton

Night time sinus
Night time sinus

Night time sinus

Acetaminophen, Doxylamine succinate, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-101
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
polyethylene glycol 400
POVIDONES
propylene glycol
water
sorbitol
GELATIN

Product Characteristics

Color Size Imprint Code Shape
BLUE 20 mm 47A CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:68016-101-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-07-13


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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