Non-Drowsy Sinus Daytime description, usages, side effects, indications, overdosage, supplying and lots more!

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Non-Drowsy Sinus Daytime

Major Pharmaceuticals

Major 44-466C


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant

Non-Drowsy Sinus Daytime Uses

  • for the temporary relief of:

    • headache

    • sinus congestion and pressure

    • minor aches and pains

    • nasal congestion

  • helps decongest sinus openings and passages

  • promotes sinus drainage

  • helps clear nasal 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

  • diabetes

  • heart disease

  • high blood pressure

  • thyroid disease

  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

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. 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)

  • adults and children 12 years and over

    • take 2 caplets every 4 hours

    • swallow whole – do not crush, chew, or dissolve

    • do not take more than 12 caplets in 24 hours

  • 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

Non-Drowsy Sinus Daytime Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C  (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

Compare to the active ingredients in Tylenol® Sinus Congestion & Pain Daytime*

MAJOR®

NDC 0904-5783-24

MAXIMUM STRENTGH
Mapap®
Sinus

CONGESTION AND PAIN

CAPLETS

Contains 2 medicine
Headache Pain  •  Acetaminophen
Sinus Pressure Nasal Congestion   •   Phenylephrine HCl

Pain Reliever - Nasal Decongestant

24 CAPLETS with Cool Blast Flavor

EASY TO SWALLOW

NON-DROWSY
DAYTIME

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Daytime.
50844    REV0612C46608
Distributed by: Major Pharmaceuticals
31788 Enterprise Drive, Livonia, MI 48150 USA        M-17
Rev. 04/13        Re-order No. 100491

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Non-Drowsy Sinus Daytime
Major 44-466C

Non-Drowsy Sinus Daytime

Acetaminophen and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5783
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Sucralose
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 17 mm 44;466 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:0904-5783-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-07-26


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