Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
- NDC Code(s): 37808-195-08, 37808-195-12, 37808-195-20
- Packager: H E B
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated October 20, 2017
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- Active ingredient (in each gelcap)
Acetaminophen 500 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
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
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- avoid high humidity
- Inactive ingredients
croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to Tylenol® Extra Strength
Rapid Release Gels active ingredient*
Pain Reliever/Fever Reducer
• For Adults
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Tylenol® Extra Strength Rapid Release Gels.
MADE WITH PRIDE AND CARE FOR
H-E-B®, SAN ANTONIO, TX 78204
If you aren't completely
pleased with this product,
we'll be happy to replace
it or refund your money.
You have our word on it.
- INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-195 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED, BLUE Score no score Shape OVAL Size 19mm Flavor Imprint Code L;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-195-08 1 in 1 CARTON 05/10/2004 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:37808-195-12 1 in 1 CARTON 05/10/2004 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:37808-195-20 225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/10/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/10/2004 Labeler - H E B (007924756) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(37808-195) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(37808-195) , PACK(37808-195) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(37808-195) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(37808-195)