Your browser does not support JavaScript! SEVERE ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [RITE AID]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

SEVERE ALLERGY AND SINUS HEADACHE (acetaminophen, diphenhydramine hcl, phenylephrine hcl) tablet
[Rite Aid]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Inactive ingredients

(in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

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
  • 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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

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. 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 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

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

RITE

AID®

PHARMACY

Compare to the active

ingredients in Benadryl® Severe

Allergy Plus Sinus Headache*

See New Warnings Information

Maximum Strength

Severe Allergy†

Plus SINUS HEADACHE

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl

Pain Reliever, Antihistamine, Nasal Decongestant

Relieves Sinus Headache, Sneezing, Runny Nose, Itchy Throat,

Sinus Congestion, Sinus Pressure & Itchy, Watery Eyes

Upper Respiratory Allergies Only

20 CAPLETS

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

50844          ORG051054309

DISTRIBUTED BY:

Rite Aid

30 Hunter Lane.

Camp Hill, PA 17011

Product Packaging

Product Packaging

SEVERE ALLERGY AND SINUS HEADACHE 
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-0543
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code 44;543
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0543-91 in 1 CARTON
120 in 1 BLISTER PACK
2NDC:11822-0543-11 in 1 CARTON
230 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/27/2007
Labeler - Rite Aid (014578892)

Revised: 8/2011
 
Rite Aid

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services