Label: DIPHENHYDRAMINE HCL capsule, liquid filled
-
Contains inactivated NDC Code(s)
NDC Code(s): 58805-001-14 - Packager: Agile Pharmachem
- 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 February 16, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
Warnings
Do not use
- If children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
- Do not use with generic NyQuil®
Ask a doctor before use if you have:
- A breathing problem such as asthma, emphysema, or Chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- You are taking a diuretic
Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :
- Avoid alcoholic beverages and other drugs that cause drowsiness
- Drowsiness will occur
- Be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.
Insomnia may be a symptom of serious underlying medical illness.
If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Questions?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58805-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) SORBITOL (UNII: 506T60A25R) Product Characteristics Color PURPLE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 602 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58805-001-14 3600 in 1 BLISTER PACK 1 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/15/2013 Labeler - Agile Pharmachem (650687853) Registrant - Agile Pharmachem (650687853)