Label: EQUALINE PAIN RELIEF PM- acetaminophen, diphenhydramine hcl tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 41163-837-71 - Packager: Supervalu Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 3, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each geltab)
- Purpose
- Uses
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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
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
- 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 lasts 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.
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Directions
- do not take more than directed (see Liver warning).
Adults and children 12 years and over:
- take 2 geltabs at bedtime
- do not take more than 2 geltabs of this product in 24 hours
Children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
EQUALINE PAIN RELIEF PM
acetaminophen, diphenhydramine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-837 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 (UNII: 68401960MK) D&C RED NO. 33 (UNII: 9DBA0SBB0L) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) 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:41163-837-71 1 in 1 CARTON 1 50 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 10/22/2004 Labeler - Supervalu Inc (006961411)
