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

allergy and cold relief

Target Corporation

  • 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
Target L-583

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

 Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenyelphrine HCl 5 mg

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant 

  •  temporarily relieves these symptoms of the common cold or hay fever or other upper respiratory allergies:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • headache
    • sore throat
    • nasal congestion
    • cough
    • minor aches and pains
    • itching of the nose or throat
  • temporarily reduces fever

Warnings

Liver Warning: This product contains acetaminophen.  Severe liver damage may occur if you take:

  • more than 23 gelcaps 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly.

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, phychiatric 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
  • thyroid disease
  • high blood pressure
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • 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 dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  •  aocohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vechile or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough 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
  • cough comes back or occurs with rash or headache that lasts

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.

  • do not use more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 12 gelcaps 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 
  • store between 20º to 25ºC (68º to 77ºF). Avoid Humidity.
  • see end flap for expiration date and lot number

colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C red #28, D&C yellow #10, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxylpropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelantinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide 

Call 1-800-910-6874 

Principal Display Panel

NDC 11673-583-08

allergy and cold relief

acetaminophen, diphenhydramine HCl, phenyephrine HCl

Compare to active ingredients in Benadryl® Allergy Plus Cold*

see new warnings information

for relief of sinus congestion/sore throat and fever/runny nose/headache/sneezing

easy to take

for ages 12 and older

24 GELCAPS

SHOWN ACTUAL SIZE ABOVE

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

50844    REV1109A58308

094 04 0072 ID39459

Distributed by Target Corporation

Minneapolis, MN 55403

©2010 Target Brands, Inc.

All Rights Reserved    Shop Target.com

Principal Display Panel

allergy and cold relief

Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11673-583
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C RED NO. 28
D&C YELLOW NO. 10
hydroxypropyl cellulose
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone
SHELLAC
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW (and pink with a gray band) 19 mm L;3 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:11673-583-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-07-10


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Be sure to consult your doctor before taking any medication!
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