Label: ALLERGY RELIEF- diphenhydramine hcl liquid
- NDC Code(s): 54859-811-16
- Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- 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 July 10, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Do not use
- with any other product conatining diphenhydramine, including one used on the skin
- to make a child sleepy
Ask a doctor before use if you have
- a breathing problem such as chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-811 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-811-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/2019 Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) Establishment Name Address ID/FEI Business Operations LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION 037342305 manufacture(54859-811)