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Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine Hydrochloride (acetaminophen 325 mg diphenhydramine hydrochloride 25 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. AAA Pharmaceutical, Inc.

Generic: acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride

Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine Hydrochloride tablet, coated - (acetaminophen 325 mg diphenhydramine hydrochloride 25 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: AAA 116     SHAPE: oval
    COLOR: blue

  1. FDA Adverse Reactions

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • 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
    • itchy, watery eyes
    • itching of the nose or throat

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
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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 to 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

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, copovidone, croscarmellose sodium, 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 - 20 Caplet Blister Pack Carton


RESTORE u

NDC 57344-126-02

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

Maximum Strength Severe Allergy & Sinus Headache

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

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

20 CAPLETS

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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