RIGHT REMEDIES PAIN RELIEF EXTRA STRENGTH CAPLET- acetaminophen tablet, coated

RIGHT REMEDIES Pain Relief Extra Strength Caplet by

Drug Labeling and Warnings

RIGHT REMEDIES Pain Relief Extra Strength Caplet by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each caplet)

Acetaminophen 500mg

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 menstrual 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
If a 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 have ever had an allergic reaction to this product or any of its ingredients.

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

Do not take more than directed. See overdose warning

• adult & children12 years of ageand over:

  take 2 caplets every 6 hours while symptoms last

  do not take more than 6 caplets in 24 hours unless directed by a doctor

  do not take more than 10 days, unless directed by a doctor

• children under12 years of age: ask a doctor

Other information

each caplet contains: sodium 1 mg (very low sodium)
store at room temperature between 20 - 25ºC (68-77ºF).
avoid excessive heat, cold and humidity.
close cap tightly after use.

Inactive ingredients

croscarmellose sodium, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone k30, purified water, sodium starch glycolate, starch corn, talc, titanium dioxide

Questions or comments?

1-888-577-8033  Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

*compare to the active ingredient of Extra Strength Tylenol®

TAMPER EVIDENT. DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

Distributed by: Strive Pharmaceuticals inc. East Brunswick, NJ 08816

Product of India

Packaged & Quality Assured in USA

READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® Extra Strength Caplets.

REV.00- 102022

Packaging

INGREDIENTS AND APPEARANCE

RIGHT REMEDIES PAIN RELIEF EXTRA STRENGTH CAPLET 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-150
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)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	18mm
Flavor		Imprint Code	S150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-150-05	50 in 1 PACKAGE; Type 0: Not a Combination Product	07/20/2022
2	NDC: 70692-150-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2022
3	NDC: 70692-150-44	1 in 1 CARTON	11/21/2023
3		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 70692-150-31	300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/20/2022

Labeler - Strive Pharmaceuticals Inc. (080028013)