EXTRA STRENGTH ACETAMINOPHEN PM- acetaminophen 500mg/ diphenhydramine hcl 25mg tablet

Extra strength Acetaminophen PM by

Drug Labeling and Warnings

Extra strength Acetaminophen PM by is a Otc medication manufactured, distributed, or labeled by TIME CAP LABS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

PURPOSE

Purpose

Pain reliever

Nighttime sleep aid

INDICATIONS & USAGE

Uses

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

WARNINGS

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

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

WHEN USING

When using this product

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue#1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide

**may contain this ingredient

QUESTIONS

Questions or comments?

Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ACETAMINOPHEN PM 
acetaminophen 500mg/ diphenhydramine hcl 25mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-430
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TALC (UNII: 7SEV7J4R1U)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE (Capsule shaped tablet)	Size	18mm
Flavor		Imprint Code	TCL430
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-430-40	400 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/22/2023

Labeler - TIME CAP LABS INC (037052099)

Registrant - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS INC		037052099	manufacture(49483-430)