Extra Strength Night Time Pain Medicine: Package Insert and Label Information

EXTRA STRENGTH NIGHT TIME PAIN MEDICINE- acetaminophen and diphenhydramine hydrochloride tablet, coated
Geri-Care Pharmaceutical Corp

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.

Active Ingredients

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

Purposes

Pain Reliever

Sleep aid

Uses

for the temporary relief of occasional headaches and minor ache and pains along 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 • glaucoma • difficulty urinating due to an enlarged prostate gland

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

• sedatives or tranquilizers

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

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 that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may 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 controlled room temperature 20-25 °C (68-77° F)

Inactive ingredients

cellulose, croscarmellose sodium, FD&C blue #1 lake,
FD&C blue #2 lake, hypromellose, magnesium
stearate, PEG, polyvinyl alcohol, povidone,
purified water, silicon dioxide, sodium starch
glycolate, starch, talc, titanium dioxide

Questions or comments?

1-800-540-3765

package Label

1
(click image for full-size original)

EXTRA STRENGTH NIGHT TIME PAIN MEDICINE
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-324
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
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
FD&C BLUE NO. 1
CROSCARMELLOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C BLUE NO. 2
TITANIUM DIOXIDE
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
WATER
SODIUM STARCH GLYCOLATE TYPE A CORN
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code P525
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-324-01 100 TABLET, COATED in 1 BOTTLE None
2 NDC:57896-324-05 50 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/01/2022
Labeler — Geri-Care Pharmaceutical Corp (611196254)
Registrant — Geri-Care Pharmaceutical Corp (611196254)

Revised: 08/2022 Geri-Care Pharmaceutical Corp

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