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- NDC Code(s): 0113-0437-71, 0113-0437-78
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 10, 2024
If you are a consumer or patient please visit this version.
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- Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
- Purpose
Pain reliever
Nighttime sleep-aid
- Uses
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 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
- •
- in children under 12 years of age
- •
- 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 have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- •
- liver disease
- •
- glaucoma
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
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
- •
- new symptoms occur
- •
- 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
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: 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 20-25°C (68-77°F)
- Inactive ingredients
carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
- Questions or comments?
1-800-719-9260
- Principal Display Panel
Extra Strength
See Alsol437 pm capsule blue ImagesPain Relief PM CAPLETS
Pain Reliever/Nighttime Sleep-Aid
Acetaminophen
Diphenhydramine HCl
For Adults
Actual Size
Compare to active ingredients of Tylenol® PM Caplets
100 Caplets
Non-Habit Forming
- INGREDIENTS AND APPEARANCE
GOOD SENSE PAIN RELIEF PMEXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0437 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light blue) Score no score Shape OVAL Size 18mm Flavor Imprint Code L437;PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0437-71 1 in 1 CARTON 07/23/1992 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0113-0437-78 1 in 1 CARTON 05/24/2021 2 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/23/1992 Labeler -L. Perrigo Company(006013346)
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Safety
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Related Resources
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More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
GOOD SENSE PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, film coated
Number of versions: 7
Published Date (What is this?) | Version | Files |
---|---|---|
Jul 11, 2024 | 7 (current) | download |
Aug 11, 2021 | 6 | download |
Dec 11, 2019 | 5 | download |
Dec 19, 2017 | 4 | download |
Dec 15, 2015 | 3 | download |
Aug 28, 2012 | 2 | download |
May 6, 2011 | 1 | download |
RxNorm
GOOD SENSE PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, film coated
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 |
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GOOD SENSE PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, film coated
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NDC Codes
GOOD SENSE PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, film coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 0113-0437-71 |
2 | 0113-0437-78 |