FDA Label for Maximum Allergy Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABELING
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
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