Severe Allergy And Sinus Headache description, usages, side effects, indications, overdosage, supplying and lots more!

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Severe Allergy And Sinus Headache

Wal-Mart Stores Inc

Equate 44-543




FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Pain reliever
Antihistamine
Nasal decongestant

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure
    • itching of the nose or throat
    • itchy, watery eyes

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
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on 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.
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • 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.

ask a health professional before use.

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.

  • do not use more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • 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
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

corn starch, crospovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Call toll free: 1-800-426-9391

NDC 49035-543-09

equate®

Compare to Benadryl® Severe Allergy Plus Sinus Headache Active Ingredients*

Maximum Strength
Severe Allergy **
& Sinus Headache
Pain Reliever, Antihistamine, Nasal Decongestant

Relieves
• Sinus headache - Acetaminophen
• Sinus congestion and sinus pressure - Phenylephrine HCl
• Sneezing - Diphenhydramine HCl
• Itchy, watery eyes - Diphenhydramine HCl
• Runny nose - Diphenhydramine HCl
• Itchy throat - Diphenhydramine HCl

**Upper Respiratory Allergies Only

20 GELCAPS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Severe Allergy Plus Sinus Headache.

50844        REV0510D54309

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

Severe Allergy And Sinus Headache
Equate 44-543

Severe Allergy And Sinus Headache

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49035-543
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POVIDONES
SILICON DIOXIDE
STEARIC ACID
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
BLUE 16 mm 44;543 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 NDC:49035-543-09 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2007-06-27


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