Label: LEGATRIN PM- acetaminophen, diphenhydramine hci tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 10237-907-50 - Packager: Church & Dwight Co., Inc.
- 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 October 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Uses
-
Warnings
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
-
Ask Doctor
Ask a doctor before use if you have
- liver disease
- glaucoma
- breathing problem such as asthma, emphysema, chronic bronchitis or pulmonary disease
- trouble urinating due to an enlarged prostate gland
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Ask a doctor or pharmacist before use if you are
- taking tranquilizers or sedatives
- taking the blood thinning drug warfarin
- When using this product
-
Stop Use
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 for more than 10 days
- fever gets worse or lasts for more than 3 days
- symptoms do not improve within 7 days or are accompanied by a fever
- new symptoms occur
- redness or swelling is present
- nervousness, dizziness or sleeplessness occur
If pregnany or breast-feeding, ask a health professional before use.
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- Package Label. Principal Display Panel LegatrinPM
-
INGREDIENTS AND APPEARANCE
LEGATRIN PM
acetaminophen, diphenhydramine hci tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-907 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color blue Score no score Shape OVAL Size 17mm Flavor Imprint Code Legatrin Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-907-50 1 in 1 CARTON 10/01/2014 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 10/01/2014 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 label(10237-907) Establishment Name Address ID/FEI Business Operations ULTRAtab 151051757 manufacture(10237-907)