DailyMed - PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

NDC Code(s): 69168-393-02, 69168-393-24, 69168-393-26, 69168-393-50, view more
69168-393-99
Packager: Allegiant Health

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 31, 2018

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Active ingredients (in each caplet)
Acetaminophen 500 mg - Diphenhydramine HCl 25 mg

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
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Purpose
Pain reliever - Nighttime sleep aid

Pain reliever
Nighttime sleep aid
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Uses
temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness

temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 4000 mg of acetaminophen in 24 hours - with other drugs containing acetaminophen - 3 or more ...
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 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
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist 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 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.
- You may report side effects to 1-888-952-0050
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If pregnant or breast-feeding,
ask a health professional before use.

ask a health professional before use.
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Keep out of reach of children
In case of accidental overdose, contact a doctor or 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 ...

In case of accidental overdose, contact a doctor or 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.

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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 ...
- 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
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Inactive Ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium ...

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose,
polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
May contain: carnauba wax, FD&C blue #2 aluminum lake, polysorbate 80

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Package/Label Principal Display Panel (What is this?)
Pain Relief Label - Pain Relief

Pain Relief Label

Pain Relief

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INGREDIENTS AND APPEARANCE

Product Information

PAIN RELIEF PM EXTRA STRENGTH acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-393
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	G651
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69168-393-02	150 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2014
2	NDC:69168-393-24	1 in 1 CARTON	12/23/2014
2		24 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:69168-393-50	1 in 1 CARTON	12/23/2014
3		50 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:69168-393-99	365 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2014
5	NDC:69168-393-26	1 in 1 CARTON	12/15/2021
5		20 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	12/23/2014

Labeler - Allegiant Health (079501930)

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Published Date (What is this?)	Version	Files
Nov 14, 2023	6 (current)	download
Oct 20, 2022	5	download
Nov 8, 2021	4	download
May 5, 2021	3	download
Feb 13, 2019	2	download

	RxCUI	RxNorm NAME	RxTTY
1	1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN
2	1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD
3	1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY

Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist if you are

When using this product

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	69168-393-02
2	69168-393-24
3	69168-393-26
4	69168-393-50
5	69168-393-99

Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist if you are

When using this product

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

Number of versions: 5

PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

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PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

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