Allergy multi-symptom 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
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • runny nose and sneezing
    • minor aches and pains
  • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose or throat
    • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus openings and passages

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.
  • 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • 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.

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
  • swallow whole - do not crush, chew, or dissolve
  • do not 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

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, hypromellose, iron oxide ochre, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

Questions or comments?

1-844-705-4384

Ingredients and appearance - Product information

Allergy multi-symptom tablet, coated- Acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 50804-828
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Chlorpheniramine maleate ( UNII: V1Q0O9OJ9Z)( Chlorpheniramine - UNII: 3U6IO1965U ) 2 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Acesulfame potassium ( UNII: 23OV73Q5G9)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Ferric oxide yellow ( UNII: EX438O2MRT)
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Magnesium stearate ( UNII: 70097M6I30)
Povidone ( UNII: FZ989GH94E)
Starch, pregelatinized corn ( UNII: O8232NY3SJ)
Propylene glycol ( UNII: 6DC9Q167V3)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color white (Off-White) Score 1
Shape OVAL Size 17 mm
Imprint Code AAA;1117 Flavor MINT

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 50804-828-03

For Adults

Allergy Multi-Symptom

Pain Reliever/Acetaminophen

Antihistamine/Chlorpheniramine Maleate

Nasal Decongestant/Phenylephrine HCl

Cool Taste; Instant Cooling Sensation

Headache

Sinus Pressure

Nasal Congestion

Runny Nose/Sneezing

Itchy, Watery Eyes

24 Caplets

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