![PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREENS]](https://medic.hrt.org//dailymed/images/c64cace3-ac67-41a3-95f5-c9fae581dfc8/apap-pm-blue-caplet-extra-strength-1.jpg)
| NDC | 0363-4470-10, 0363-4470-11, 0363-4470-15, 0363-4470-24, 0363-4470-30, 0363-4470-52 |
| Set ID | c64cace3-ac67-41a3-95f5-c9fae581dfc8 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Walgreens |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
-
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 products 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 problems such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
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
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
- Directions
- Other information
-
Inactive ingredients
carnauba wax*, croscarmellose sodium*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, polyvinyl alcohol*, povidone K30, pregelatanized starch, purified water*, silicon dioxide*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide
*contains one or more of these ingredienrts
- Questions or comments?
-
Principal Display Panel
Compare to Extra Strength Tylenol® PM active ingredients††
Pain Reliever PM
ACETAMINOPHEN 500 mg/ PAIN RELIEVER
DIPHENHYDRAMINE HCl 25 mg/ NIGHTTIME SLEEP AID
NIGHTTIME EXTRA STRENGTH CAPLETS
CAPLETS**
(**CAPSULES-SHAPED TABLETS)
††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Package Label
-
INGREDIENTS AND APPEARANCE
PAIN RELIEVER PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4470 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code S525;P525;G651 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4470-10 1 in 1 BOX 12/30/2014 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0363-4470-15 1 in 1 BOX 12/30/2014 2 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:0363-4470-24 1 in 1 BOX 12/30/2014 3 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:0363-4470-11 1 in 1 BOX 12/30/2014 4 110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:0363-4470-30 1 in 1 BOX 12/30/2014 5 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:0363-4470-52 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/30/2014 Labeler - Walgreens (008965063)
