OTC Medication Information: Pain Relief Extra Strength

PAIN RELIEF EXTRA STRENGTH — acetaminophen tablet
Select Corporation

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.

Active Ingredients


Analgesic, Antipyretic

Directions: Adults and children
12 years of age and older: • take 2 tablets every 4 to 6 hours
as needed • do not take more than 8 tablets in 24 hours. Children
under 12 years of age: • do not use this extra strength product; this
will provide more than the recommended dose (overdose) and
could cause serious health problems.

Uses: • temporary relief of minor aches and pains associated with
• common cold • headache • backache • arthritis • toothache •
muscular aches • menstrual cramps • and reduction of fever

Warnings:
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take • more than 8 tablets 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. Ask a doctor before use if you have: liver
disease. Ask a doctor or pharmacist before use if you are:
taking the blood thinning drug warfarin. Stop use and ask a
doctor if: • pain gets worse or lasts for more than 10 days • a
rare sensitivity reaction occurs • fever gets worse or lasts more
than 3 days • symptoms do not improve • new symptoms occur •
redness or swelling is present. You may report side effects to
888-952-0050.

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

KEEP OUT OF REACH OF CHILDREN.

Inactive ingredients: corn starch, hydoxypropyl methylcellulose,
polyethylene glycol, pregelatinized starch, stearic acid, titaniumdioxide. May contain povidone and sodium starch glycolate

MM1

Pain ES Packet
(click image for full-size original)
PAIN RELIEF EXTRA STRENGTH acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-446
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POLYETHYLENE GLYCOL 300
STEARIC ACID
TITANIUM DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K29/32
Product Characteristics
Color white (snow white) Score no score
Shape ROUND (AZ235) Size 12mm
Flavor Imprint Code AZ235
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52904-446-02 2 TABLET (TABLET) in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/15/2012
Labeler — Select Corporation (053805599)
Registrant — Select Corporation (053805599)

Revised: 10/2012 Select Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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