FDA Label for Maximum Allergy Relief

View Indications, Usage & Precautions

Maximum Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Western First Aid Safety Dba Aramark. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Drug Facts

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


Otc - 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


Otc - 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.


Otc - 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


Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product do not exceed
recommended dose


Otc - 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.


Otc - Pregnancy Or Breast Feeding



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


Otc - 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


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