Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HCL- acetaminophen and diphenhydramine hcl tablet
Contains inactivated NDC Code(s)
NDC Code(s): 68151-0703-0
- Packager: Carilion Materials Management
- This is a repackaged label.
- Source NDC Code(s): 0536-3479
- 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.
Updated December 26, 2017
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- Active Ingrdient
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 captabs in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product.
Do not use
- 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 drug containing diphenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- 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 the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- marked drowsiness will occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- do not drive motor vehicle or operate machinery
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
- sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness.
If pregnant or breast feeding, ask a health professional before use.
Keep out of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
- Other Information
- Inactive Ingredients
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND DIPHENHYDRAMINE HCL
acetaminophen and diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68151-0703(NDC:0536-3479) 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (light blue) Score no score Shape CAPSULE Size 17mm Flavor Imprint Code AP;133 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68151-0703-0 1 in 1 PACKAGE; Type 0: Not a Combination Product 10/06/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/06/2010 Labeler - Carilion Materials Management (079239644) Establishment Name Address ID/FEI Business Operations Carilion Materials Management 079239644 REPACK(68151-0703)