EXTRA STRENGTH ACETAMINOPHEN PM: Package Insert and Label Information

EXTRA STRENGTH ACETAMINOPHEN PM- acetaminophen and diphenhydramine hydrochloride tablet
Spirit Pharmaceutical LLC

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.

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500mg Pain reliever
Diphenhydramine HCl 25mg Nighttime Sleep aid

Uses

for the 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 with this product 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 you are 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 other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • in children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

  • liver disease
  • breathing problems such as emphysema or chronic bronchitis
  • trouble urinating due to an enlargement of the 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

  • 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 a serious underlying medical illness
  • pain gets worse or lasts for 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

Taking more than the directed dose (overdose) may cause liver damage. 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 of age and over:
  • take 2 caplets at bedtime or as directed by a doctor
  • do not take more than 2 caplets in a 24 hour period
children under 12 years of age:
  • do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • each caplet contains: magnesium 0.05 mg
  • store between 20°-25°C (68°-77°F)
  • see end panel for lot number and expiration

Inactive ingredients

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-888-333-9792

DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA

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EXTRA STRENGTH ACETAMINOPHEN PM
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1000
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSE 2208 (15000 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, CORN
POVIDONE K30
STEARIC ACID
TITANIUM DIOXIDE
WATER
Product Characteristics
Color blue Score no score
Shape OVAL Size 18mm
Flavor Imprint Code S525
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-1000-5 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET in 1 BOTTLE This package is contained within the CARTON (68210-1000-5)
2 NDC:68210-1000-1 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (68210-1000-1)
3 NDC:68210-1000-2 1 BOTTLE in 1 CARTON contains a BOTTLE
3 24 TABLET in 1 BOTTLE This package is contained within the CARTON (68210-1000-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/12/2016
Labeler — Spirit Pharmaceutical LLC (179621011)
Establishment
Name Address ID/FEI Operations
ELYSIUM PHARMACEUTICALS LTD 915664486 manufacture (68210-1000)

Revised: 02/2020 Spirit Pharmaceutical LLC

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