![GOOD SENSE PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [L. PERRIGO COMPANY]](https://medic.hrt.org//dailymed/images/2633ff8c-0f03-4ec6-beaa-e5c5163b8995/837-c2-pain-relief-pm.jpg)
| NDC | 0113-0837-71 |
| Set ID | 2633ff8c-0f03-4ec6-beaa-e5c5163b8995 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L. Perrigo Company |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredients (in each geltab)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other product containing diphenhydramine, even one used on skin
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- in children under 12 years of age
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- drowsiness will occur
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- avoid alcoholic drinks
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- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
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- sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
These could be signs of a serious condition.
- Directions
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
GOOD SENSE PAIN RELIEF PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0837 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 CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) D&C RED NO. 33 (UNII: 9DBA0SBB0L) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE, WHITE Score no score Shape ROUND (Convex) Size 12mm Flavor Imprint Code L837 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0837-71 1 in 1 CARTON 01/26/1998 1 50 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 01/26/1998 Labeler - L. Perrigo Company (006013346)
