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Acetaminophen and Diphenhydramine hydrochloride

제형
TABLET
업체
Aurohealth LLC
원문 갱신
2023-11-29
가져온 날
2026-09-07
유효 성분
ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
DailyMed 원문·등록 이미지 확인 ↗
유효 성분Drug Facts

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg
Diphenhydramine hydrochloride USP 25 mg

성분·작용Purpose

Pain reliever
Nighttime sleep aid

효능·용도Uses

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

주의사항Warnings

Liver warning:This product contains acetaminophen.
Severe liver damage may occur if you take

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 useDo 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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • in children under 12 years of age
Ask a doctor before use if you haveAsk a doctor before use if you have
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
Ask a doctor or pharmacist before use if you areAsk a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
When using this productWhen using this product
  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
Stop use and ask a doctor ifStop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

복용법·사용법Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 gelcaps at bedtime
    • do not take more than 2 gelcaps of this product in 24 hours.
  • children under 12 years: do not use
보관·기타 정보Other information
  • avoid high humidity
  • store at 20º to 25°C (68º to 77°F)
  • use by expiration date on package
첨가제Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

제조사 문의Questions or comments?

1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton- Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

포장 표시PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg/25 mg (20 Gelcaps Bottle)

AUROHEALTH
NDC 58602-760-73


EXTRA STRENGTH
Acetaminophen and
Diphenhydramine Hydrochloride
Gelcaps 500 mg/25 mg
Pain Reliever,
Nighttime Sleep Aid

Non-Habit Forming

Rapid Release

20 GELCAPS



[Image in the official label — see DailyMed source]

포장 표시PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg/25 mg (20 Gelcaps Bottle Carton)

AUROHEALTH
Compare to the active ingredients in
Extra Strength Tylenol ®PM
NDC 58602-760-73

EXTRA STRENGTH

Acetaminophen and
Diphenhydramine
Hydrochloride Gelcaps 500 mg/25 mg
Pain Reliever,
Nighttime sleep aid
Non-habit forming
Rapid Release
  20 GELCAPS



[Image in the official label — see DailyMed source]

DailyMed Set ID: 3ba51b52-7ae6-4335-b178-1b7b6ef36227 · 버전 2
NDC: 58602-760