OTC Medication Information: EXTRA STRENGTH PAIN RELIEF

EXTRA STRENGTH PAIN RELIEF- acetaminophen suspension
Preferred Pharmaceuticals Inc.

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 ingredient (in each 15mL Tablespoonful)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses

temporarily relieves minor aches and pains
temporarily reduces fever

Warnings

Liver Warning: This product contains acetaminophen. The maximum
daily dose of this product is 6 tablespoonfuls in 24 hours.
Severe liver damage may occur if you take
• more than 8 tablespoonfuls (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 severe skin reactions.
Symptoms may include: • skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

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

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Directions

do not take more than directed

Adults and children 12 years of age and older

Take 1-2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours

Children under 12 years

Do not use

Other information

store at room temperature 15°- 30°C (59°-86°F)
protect from freezing
protect from light
TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.

Inactive ingredients

artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments?

1-800-540-3765

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

Extra Strength APAP Liquid 500mg per 15mL
(click image for full-size original)
EXTRA STRENGTH PAIN RELIEF
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8375(NDC:57896-206)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
METHYLPARABEN
POLYETHYLENE GLYCOL, UNSPECIFIED
SUCRALOSE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE, UNSPECIFIED FORM
Product Characteristics
Color red Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8375-2 237 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 02/24/2023
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-8375)

Revised: 02/2023 Preferred Pharmaceuticals Inc.

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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