MAXIMUM ALLERGY RELIEF- acetaminophen, phenylephrine hcl tablet

Maximum Allergy Relief by

Drug Labeling and Warnings

Maximum Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Western First Aid Safety DBA Aramark, ULTRA SEAL CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredient (in each tablet)
Acetaminophen 500 mg
Phenylephrine HLC 5 mg

PURPOSE

Purpose
Acetaminophen ...................Pain reliever/fever reducer
Phenylephrine HLC ................Nasal decongestant

INDICATIONS & USAGE

Uses:
Temporarily relieves these symptoms
associated with hay fever or other
respiratory allergies and the common cold:

headache                   sinus congestion and pressure
nasal congestion       minor aches and pains
                                    promotes sinus drainage
                                    temporarily reduces fever

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
product

Allergy 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 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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug Warfarin

WHEN USING

When using this product do not exceed
recommended dose

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health
professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
Overdose warning: in case of overdose, get
medical help or contact a Poison Control Center
right away. (1-800-222-1222) Quick medical
attention is critical for adults as well as for children
even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions:
do not take more than directed (see
  overdose warning)
adults and children 12 years and over:
  take 2 tablet every 4 hours
  swallow whole; do not crush, chew or
  dissolve
  do not take more than 6 tablets in 24
     hours
children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information:
read all warnings and directions before use. Keep
carton. Store at 20-25°C (68-77°F) avoid excessive
heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive Ingredients:
Corn Starch, FD & C Blue #1 Lake, Microcystalline
Cellulose, Povidone, Sodium Starch Glycolate,
Stearic Acid, USP Purified Water

Package Labeling

aramark

100 TABLETS         Part # 91933B
PER BOX

Maximum
Allergy Relief
Pain Reliever/Nasal Decongestant

Temporary relief of headaches,
sinus pain, nasal and sinus congestion,
minor aches, pains, fever

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
(913) 269-9611

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

250 Tablet Box

2-Tablet Packet

res

INGREDIENTS AND APPEARANCE

MAXIMUM ALLERGY RELIEF 
acetaminophen, phenylephrine hcl tablet

Product 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)