ALLERGY AND COLD- acetaminophen, diphenhydramine hcl and phenylephrine hcl capsule, gelatin coated

Allergy and Cold by

Drug Labeling and Warnings

Allergy and Cold by is a Otc medication manufactured, distributed, or labeled by WOONSOCKET PRESCRIPTION CENTER,INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

• 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 12 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 vomiting, 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, 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
• 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 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
• 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.

Directions

• 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

Other information

• store between 20º to 25ºC (68º to 77ºF).  Avoid high humidity.
• see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

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 Cold

NEW!

ALLERGY & COLD

WITH FEVER REDUCER

ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

Pain reliever/Fever reducer, Antihistamine/Cough suppressant,

Nasal decongestant

See New Warnings Information

Relief of:

✓ Headache    

✓ Sneezing

✓ Sore throat & Fever

✓ Itchy, watery eyes

✓ Sinus congestion

✓ Runny nose

✓ Itchy Throat

✓ Cough

24 GELCAPS

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

Distributed by:

CVS Pharmacy, Inc.

One CVS Dive

Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

50844   ORG110958308

INGREDIENTS AND APPEARANCE

ALLERGY AND COLD 
acetaminophen, diphenhydramine hcl and phenylephrine hcl capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-583
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	YELLOW (pink with grey band)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	L;3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-583-08	1 in 1 CARTON
1		24 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/10/2009

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)