Label: RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF- acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coated
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-559-08 - Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 16, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each gelcap)
- Purpose
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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
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
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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.
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.
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Directions
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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
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do not take more than directed
- Other information
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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?
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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, AntihistamineContains 3 medicines
• Headache - Acetaminophen
• Sinus pressure/Nasal Congestion - Phenylephrine HCl
• Runny nose/Sneezing
Itchy, Watery eyes - Chlorpheniramine maleatePseudoephedrine Free
24
GELCAPSDistributed 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 REV0812A55908TAMPER 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
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INGREDIENTS AND APPEARANCE
RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF
acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coatedProduct 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)