Label: MAXIMUM ALLERGY RELIEF- acetaminophen, phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 81238-0240-1, 81238-0240-2 - Packager: Western First Aid Safety DBA Aramark
- 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 June 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 6 tablets
(3,000 mg acetaminophen) in 24 hours. Severe liver
damage may occur if you take:
•more than 4,000 mg of acetaminophen in 24 hours
•with other drugs containing acetaminophen
•3 or more alcoholic drinks every day while using this
productAllergy alert: acetaminophen may cause serve skin
reactions. Symptoms may include:
•skin reddening •blister •rash
If a skin reaction occurs, stop use and seek medical
help right away -
DO NOT USE
Do not use
•with any other drug containing acetaminophen. 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 (MAOIs), 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.
•if you have ever had an allergic reaction to this
product or any of its ingredients. - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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Package Labeling
aramark
100 TABLETS Part # 91933B
PER BOXMaximum
Allergy Relief
Pain Reliever/Nasal DecongestantTemporary relief of headaches,
sinus pain, nasal and sinus congestion,
minor aches, pains, feverMANUFACTURED FOR:
Aramark
Lenexa, KS 66219
(913) 269-9611aramarkuniform.com
Retain carton for complete product information
100 Tablet Box
250 Tablet Box
2-Tablet Packet
res
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INGREDIENTS AND APPEARANCE
MAXIMUM ALLERGY RELIEF
acetaminophen, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-0240 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score no score Shape ROUND Size 12mm Flavor Imprint Code FR33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81238-0240-1 50 in 1 BOX 05/07/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:81238-0240-2 125 in 1 BOX 05/07/2021 2 2 in 1 PACKET; 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 05/07/2021 Labeler - Western First Aid Safety DBA Aramark (043861524) Registrant - Western First Aid Safety DBA Aramark (043861524) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(81238-0240) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 944090448 manufacture(81238-0240)