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Name:Allergy And Sinus Headache
Manufacturer:Woonsocket Prescription Center, Incorporated
Category:Over-the-counter (OTC) Marketed Drugs


ALLERGY AND SINUS HEADACHE - acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride tablet 
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Disclaimer: 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.

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Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves theses symptoms of hay fever and the common cold
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
  • temporarily relieves these additional symptoms of hay fever:
  • 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
  • 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
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehical 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 59°-77°F in a dry place
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, drospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

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.

CVS®

pharmacy

Compare to the active ingredients in

Benadryl® Allergy Plus Sinus Headache*

See New Warnings Information

ALLERGY &

SINUS

HEADACHE

PAIN & PRESSURE RELIEF

PAIN RELIEVER / ANTIHISTAMINE / NASAL DECONGESTANT

Acetaminophen

Sinus Headache

Phenylephrine HCl

Sinus Congestion

Sinus Pressure

Diphenhydramine HCl

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 CAPLETS

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

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com                  1-800-shop-CVS

Product Label

ALLERGY AND SINUS HEADACHE  
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-464
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 12.5 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn  
Croscarmellose Sodium  
Crospovidone  
D&c Yellow No. 10  
Fd&c Blue No. 1  
Fd&c Red No. 40  
Magnesium Stearate  
Cellulose, Microcrystalline  
Polyethylene Glycol  
Polyvinyl Alcohol  
Povidone  
Silicon Dioxide  
Stearic Acid  
Talc  
Titanium Dioxide  
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 44;464
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-464-08 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 24 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-464-08)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/15/2005

Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
Name Address ID/FEI Operations
L.N.K. International, Inc 832867894 MANUFACTURE

Revised: 08/2010 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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