ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE- acetaminophen, diphenhydramine hydrochloride tablet, film coated
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0752-Cardinal

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep-aid

Uses

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

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
drowsiness will occur

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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 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 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: do not use

Other information

store at room temperature

croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

(800) 231-4670

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Acetaminophen, Diphenhydramine Hydrochloride

GENERIC: Acetaminophen, Diphenhydramine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2740-0

COLOR: blue

SHAPE: OVAL

SCORE: No score

SIZE: 17 mm

IMPRINT: CPC752

PACKAGING: 50 in 1 BOTTLE

ACTIVE INGREDIENT(S):

DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1
ACETAMINOPHEN 500mg in 1

INACTIVE INGREDIENT(S):

TALC
TITANIUM DIOXIDE
STEARIC ACID
LIGHT MINERAL OIL
D&C YELLOW NO. 10
MAGNESIUM STEARATE
TRIACETIN
FD&C BLUE NO. 1
CROSCARMELLOSE SODIUM
POVIDONE K30
STARCH, CORN
SILICON DIOXIDE
HYPROMELLOSES
SODIUM STARCH GLYCOLATE TYPE A POTATO

Remedy_Label

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen, diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2740(NDC:70000-0411)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TRIACETIN (UNII: XHX3C3X673)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	CPC752
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-2740-0	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2020	10/16/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/12/2020	10/16/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023

Document Id: 07d70030-ece4-e1c3-e063-6394a90a3d47

Set id: 43fba3c6-412e-41bb-a627-0a48e5261a9e

Version: 4

Effective Time: 20231016

REMEDYREPACK INC.