Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

AAA Pharmaceutical, Inc.

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Diphenhydramine HCl 12.5 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Uses

  • temporarily relieves these symptoms of hay fever and the common cold:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
  • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose or throat
    • itchy, watery eyes

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.
  • 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.

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
  • 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

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

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

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Other information

  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

RESTORE u

NDC 57344-125-02

COMPARE TO THE ACTIVE
INGREDIENTS IN BENADRYL®
ALLERGY PLUS SINUS HEADACHE

Allergy &
Sinus Headache

Pain Reliever, Antihistamine, Nasal Decongestant
Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI

Relieves:
  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Sinus Congestion
  • Sinus Pain & Presssure
  • Sinus Headache

24 CAPLETS

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-125
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
COPOVIDONE K25-31
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
POVIDONES
STARCH, CORN
propylene glycol
PROPYLPARABEN
sodium starch glycolate type a corn
STEARIC ACID
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
GREEN 17 mm AAA;115 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 12 in 1 BLISTER PACK
3 NDC:57344-125-03 4 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-22


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