RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF- acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coated

Rapid Release Multi-Symptom Allergy Relief by

Drug Labeling and Warnings

Rapid Release Multi-Symptom Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylepherine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

Uses

• temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • sinus congestion and pressure
  • nasal congestion
  • runny nose and sneezing
  • headache
  • 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 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

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 taking 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
• diabetes
• heart disease
• high blood pressure
• thyroid disease
• 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
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• drowsiness may occur

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
• new symptoms occur
• redness or swelling is present

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 (1-800-222-1222) 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 take 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

• see end flap for expiration date and lot number
• store at 25ºC (77º); excursions permitted between 15º to 30ºC (59º-86ºF)
• contains FD&C yellow #5 (tartrazine) as a color additive

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C red #3, FD&C red #40, FD&C yellow #5, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

Questions?

1-888-287-1915

Principal display panel

NDC: 49035-559-08

equate®

Compare to Tylenol® Allergy Multi-Symptom Active Ingredients*

Rapid Release
Multi-Symptom
Allergy Relief
Pain reliever, Nasal decongestant, Antihistamine

Contains 3 medicines
Headache - Acetaminophen
Sinus pressure/Nasal Congestion - Phenylephrine HCl
Runny nose/Sneezing
   Itchy, Watery eyes - Chlorpheniramine maleate

Pseudoephedrine Free

24
GELCAPS

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 
©Wal-Mart Stores, Inc.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Allergy Multi-Symptom.
50844        REV0812A55908

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

Equate 44-559

INGREDIENTS AND APPEARANCE

RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF 
acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-559
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)

Product Characteristics
Color	YELLOW (red with grey band)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	L;9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-559-08	1 in 1 CARTON
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/17/2008

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(49035-559)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(49035-559)