allergy description, usages, side effects, indications, overdosage, supplying and lots more!

allergy

Kroger Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Kroger Co. Allergy Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •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.
  • •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
  • •to make a child sleepy

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
  • •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.

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

  • •do not take more than directed (see Liver warning)

Inactive ingredients

acesulfame potassium, carnauba wax, flavor, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

COOL ICE®

INSTANT COOLING SENSATION

COMPARE TO active ingredients of TYLENOL® ALLERGY MULTI-SYMPTOM

See end panel

SEE NEW WARNINGS AND DIRECTIONS

May Cause Drowsiness

Allergy

Multi-Symptom

Pain Reliever/Nasal Decongestant/Antihistamine

Acetaminophen/Chlorpheniramine Maleate

Phenylephrine HCl

Headache/Sinus Pressure

Nasal Congestion

Runny Nose/Sneezing

Itchy, Watery eyes

Actual Size

allergy

Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-476
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
carnauba wax
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
STEARIC ACID
talc
titanium dioxide
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
WHITE (off white) 19 mm L476 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:30142-476-62 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-08-21


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Be sure to consult your doctor before taking any medication!
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