Sinus Congestion and Pain Daytime Nighttime description, usages, side effects, indications, overdosage, supplying and lots more!

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Sinus Congestion and Pain Daytime Nighttime

AAA Pharmaceutical, Inc.

Sinus Congestion & Pain Daytime/Nighttime


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SINUS CONGESTION & PAIN DAY

Drug Facts

Active ingredient

Purpose

Active ingredients (in each day caplet) Purpose
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant

Sinus Congestion and Pain Daytime Nighttime Uses

  • for the temporary relief of:
    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages

SINUS CONGESTION & PAIN NIGHT

Drug Facts

Active ingredient

Purpose

Active ingredients (in each night caplet) Purpose
Acetaminophen 325 mg Pain reliever
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant

Sinus Congestion and Pain Daytime Nighttime Uses

  • for the temporary relief of:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • runny nose and sneezing
    • minor aches and pains
  • reduces swelling of nasal passages
  • helps decongest sinus openings and passages

Warnings

Liver warning

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

  • more than 12 caplets 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

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
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble 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

In addition, when using Sinus Congestion & Pain Night:

  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

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

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Directions

  • do not take more than directed (see overdose warning)
  • do not take Day and Night caplets at the same time
  • do not take more than a total of 12 caplets in 24 hours
adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew, or dissolve
children under 12 years
  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Sinus Congestion and Pain Daytime Nighttime Other information

  • store between 20º-25ºC (68º-77ºF) in a dry place
  • retain carton for complete product information

Inactive ingredients

Sinus Congestion & Pain Day

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C blue #1, flavor, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide

Sinus Congestion & Pain Night

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, hypromellose, iron oxide ochre, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 57344-149-02

RESTORE u

COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL®
SINUS CONGESTION & PAIN -
DAY & NIGHT

DAYTIME
NON-DROWSY

NIGHTTIME

Sinus
CONGESTION & PAIN

Pain Reliever, Nasal Decongestant, Antihistamine*

  • Headache – Acetaminophen
  • Nasal Congestion – Phenylephrine HCl
  • Runny Nose* – Chlorpheniramine Maleate*

*Antihistamine in Nighttime Only

COOL TASTE

20 CAPLETS 12 DAY / 8 NIGHT CAPLETS

Sinus Congestion and Pain Daytime Nighttime

Sinus Congestion and Pain Daytime Nighttime

Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-149
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-149-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-28


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Be sure to consult your doctor before taking any medication!
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