TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated 
Savings Distributors LLC

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.

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Tylenol Extra Strength

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ the common cold ■ headache

■ backache ■ minor pain of arthritis

■ toothache ■ muscular aches

■ premenstrual and menstual cramps

■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. 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 severe skin reactions.symptoms may include:

■ skin reddening ■ blisters ■ rash

Ifa skin reaction occurs, stop use and seek medical help right away.

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.

■ 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

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present.

These could be signs of a serious condition.

If pregnant or breast-feeding,

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. (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.

Directions

do not take more than directed (see overdose warning).

adults and children ■ take 2 capletes every 6 hours while symptoms

12 years and over: last
■ do not take more than 6 capletes in 24 hours,

unless directed by a doctor
■ do not use for more than 10 days unless

directed by a doctor

children under 12 years ask a doctor

Other information

■ store between 20-25C (68-77F)

■ do not use if pouch is torn or damaged.

Inactive ingredients

carnauba wax*, corn starch*, FD&C red no.40 aluminum lake, hypromellose, magnesium stearate, modified starch*, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

* contains one or more of these ingredients

Questions or comments?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Package Labeling

Package Label

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-012(NDC:50580-449)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73097-012-021 in 1 CARTON07/22/2019
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:73097-012-4020 in 1 CARTON07/22/2019
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:73097-012-5025 in 1 BOX07/22/2019
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/22/2019
Labeler - Savings Distributors LLC (010527359)
Establishment
NameAddressID/FEIBusiness Operations
Savings Distributors LLC010527359repack(73097-012)

Revised: 7/2019
Document Id: 8ed86a8b-b7f5-0d01-e053-2995a90aac99
Set id: 8ed90757-833e-f4d9-e053-2995a90a29db
Version: 1
Effective Time: 20190729
 
Savings Distributors LLC