Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine Hydrochloride
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-126
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients |
(in each caplet)
|Acetaminophen 325 mg||Pain reliever|
|Diphenhydramine HCl 25 mg||Antihistamine|
|Phenylephrine HCl 5 mg||Nasal decongestant|
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- minor aches and pains
- nasal congestion
- sinus congestion and pressure
- itchy, watery eyes
- itching of the nose or throat
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
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- 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
- 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
- do not take more than directed (see overdose warning)
|adults and children 12 years and over||
|children under 12 years||
- store between 20°-25°C (68°-77°F) in a dry place
- retain carton for complete product information
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
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
†COMPARE TO THE ACTIVE
INGREDIENTS IN BENADRYL®
SEVERE ALLERGY PLUS
Severe Allergy &
Pain Reliever, Antihistamine, Nasal Decongestant
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
- Sinus Congestion
- Itchy, Watery Eyes
- Sinus Pain & Presssure
- Runny Nose
- Sinus Headache
|ACETAMINOPHEN, DIPHENHYDRAMINE HYHROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
|Labeler - AAA Pharmaceutical, Inc. (181192162)|
|AAA Pharmaceutical, Inc.||181192162||MANUFACTURE(57344-126)|
|AAA Pharmaceutical, Inc.||010411533||PACK(57344-126)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.