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- NDC Code(s): 36800-437-71, 36800-437-78
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated April 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
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- Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
- Purpose
Pain reliever
See AlsoPain Relief PM Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMDl437 pm OVAL BLUE Imagesdiphenhydramine-acetaminophen oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMDDailyMed - GOOD SENSE PAIN RELIEF PM EXTRA STRENGTHNighttime 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
- •
- 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
- •
- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
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.
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
- 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?
1-888-423-0139
- Principal Display Panel
TopCare® health
COMPARE TO EXTRA STRENGTH TYLENOL® PM ACTIVE INGREDIENTS
EXTRA STRENGTH
NIGHTTIME
Pain Relief PM
ACETAMINOPHEN 500 mg, DIPHENHYDRAMINE HCl 25 mg
PAIN RELIEVER • NIGHTTIME SLEEP-AID
Non-Habit Forming
50 CAPLETS
For Adults
actual size
PM
- INGREDIENTS AND APPEARANCE
TOPCARE PAIN RELIEF PMEXTRA STRENGTH NON HABIT FORMING
acetaminophen, diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-437 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 (15 MPA.S AT 5%) (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:36800-437-71 1 in 1 CARTON 07/21/1992 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:36800-437-78 1 in 1 CARTON 07/21/1992 08/08/2015 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 not final part343 07/21/1992 Labeler -Topco Associates LLC(006935977)
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Find additional resources
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Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- acetaminophen, diphenhydramine hcl tablet, film coated
Number of versions: 8
| Published Date (What is this?) | Version | Files |
|---|---|---|
| May 23, 2023 | 8 (current) | download |
| Nov 16, 2021 | 7 | download |
| Dec 3, 2019 | 6 | download |
| Jun 21, 2018 | 5 | download |
| Dec 19, 2017 | 4 | download |
| Dec 9, 2015 | 3 | download |
| Aug 28, 2012 | 2 | download |
| Oct 9, 2010 | 1 | download |
RxNorm
TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- 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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TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- acetaminophen, diphenhydramine hcl tablet, film coated
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NDC Codes
TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING- 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 | 36800-437-71 |
| 2 | 36800-437-78 |
