Severe allergy relief plus sinus headache tablet, coated

Spl unclassified section

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

Allergy alert

acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

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
  • ask a doctor

Other information

  • store between 20-25C (68-77F) 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, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Ingredients and appearance - Product information

Severe allergy relief plus sinus headache tablet, coated- Acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 50804-473
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Copovidone k25-31 ( UNII: D9C330MD8B)
Croscarmellose sodium ( UNII: M28OL1HH48)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Hypromelloses ( UNII: 3NXW29V3WO)
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Magnesium stearate ( UNII: 70097M6I30)
Povidone ( UNII: FZ989GH94E)
Starch, pregelatinized corn ( UNII: O8232NY3SJ)
Propylene glycol ( UNII: 6DC9Q167V3)
Sodium starch glycolate type a corn ( UNII: AG9B65PV6B)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color blue Score 1
Shape OVAL Size 17 mm
Imprint Code AAA;116

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - GoodSense( 076059836)

Principal display panel

GoodSense
NDC 50804-473-02
Maximum Strength
Pain Reliever
Nasal Decongestant
Antihistamine
Severe Allergy Relief
Plus Sinus Headache
Acetaminophen
Phenylephrine HCl
Diphenhydramine HCl
Sinus Headache
Sinus Pressure & Congestion
Runny Nose & Itchy Throat
Itchy, Watery Eyes
Sneezing
20 CAPLETS
Compare to active ingredients of Benadryl® Severe Allergy Plus Sinus Headache
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