RIGHT REMEDIES EXTRA STRENGTH PM PAIN RELIEF- acetaminophen, diphenhydramine hydrochloride tablet, film coated

RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief by

Drug Labeling and Warnings

RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief 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 ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purposes

Pain reliever
Nighttime sleep aid

Uses

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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  with any other product containing diphenhydramine, even one used on skin 
 in children under 12 years of age   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  a breathing problem such as emphysema or chronic bronchitis   trouble urinating due to an enlarged prostate gland  glaucoma

Ask a doctor or a pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product drowsiness will occur  avoid alcoholic drinks  do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness  pain gets worse or lasts more than 10 days  fever gets worse or lasts more than 3 days  redness or swelling is present  new symptoms occur.
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)
do not take more than 2 caplets in 24 hours

• adults & children 12 years of age and over:

  take 2 caplets at bedtime; do not take more than 2 caplets of this product in 24 hours

• children under 12 years of age: do not use

Other information

each caplet contains: sodium 3 mg (very low sodium)
store at room temperature between 20-25ºC (68-77ºF).
avoid excessive heat, cold and humidity.

Inactive ingredients

croscarmellose sodium, FD&C blue#1 aluminium lake, FD&C blue#2 aluminium lake, hypromelloses, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone K30, purified water, silicon dioxide, sodium starch glycolate, starch, talc, titanium dioxide

Questions or comments?

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

SPL UNCLASSIFIED SECTION

compare to active ingredients of Extra Strength TYLENOL® PM*

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

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

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

Product of India

Packaged & Quality Assured in USA

CT7069214903
REV.00-082021

Packaging

INGREDIENTS AND APPEARANCE

RIGHT REMEDIES EXTRA STRENGTH PM PAIN RELIEF 
acetaminophen, diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-149
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	S149
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-149-03	1 in 1 CARTON	11/13/2023
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 70692-149-31	300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2023
3	NDC: 70692-149-05	1 in 1 CARTON	11/13/2023
3		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/13/2023

Labeler - Strive Pharmaceuticals Inc. (080028013)