Uses
1 INDICATIONS & USAGE
4 CONTRAINDICATIONS
Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
Cephalexin
- Manufacturer
- Bryant Ranch Prepack
- Effective date
- 2024-07-26
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 107
- Source
- full-release
- Hydrated at
- 2026-05-31 21:11:19
Key Label Information#
Warnings
4 CONTRAINDICATIONS
Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
5 WARNINGS AND PRECAUTIONS
Directions And Dosage
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
Cephalexin For Oral Suspension USP 125 mg/5mL and 250 mg/5mL
10 OVERDOSAGE
Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.
Other Label Information
16 HOW SUPPLIED/STORAGE AND HANDLING
Cephalexin Oral Suspension, USP250 mg/5 mL: NDC: 63629-8858-1: 200 For Suspensions in a BOTTLE Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Shake well before using. Keep tightly closed. *After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cephalexin 250mg/5mL Susp #200 Extended Label
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CEPHALEXIN ANHYDROUS Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dfa3f520-409c-432e-b6d3-9250d468c772 | Product name | 1 | 20250401 |
| 64bb7f1a-2c2e-4741-8301-dbfeda7239f6 | Product name | 1 | 20190628 |
| 398aa563-bb78-fe0f-46a8-757c40ef28bf | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-8858-1 | Cephalexin | 200 mL in 1 BOTTLE | FOR SUSPENSION | 200 | 107 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-8858 | CEPHALEXIN FOR SUSPENSION [BRYANT RANCH PREPACK] | 107 | Current NDC, Legacy NDC, 1 package rows | 20240823_df6bb893-e3d7-4c8f-8cec-35b4d2fa33b3.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-8858-1 | ML - Milliliter | 63629-8858 | 6f48e422-0f79-4b8b-82c6-c8b6925aff14 | 1 | 2021-12-08 |
| 67877-545-68 | ML - Milliliter | 67877-545 | 359b41ac-c726-4030-824e-4ace50e8570d | 1 | 2019-06-19 |
| 67877-545-88 | ML - Milliliter | 67877-545 | 86d98301-4141-47bf-af78-75da718f60c7 | 1 | 2019-06-19 |
Products#
- CEPHALEXIN ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63629-8858 | 63629-8858-1 |
| 67877-545 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| CEPHALEXIN | OBN7UDS42Y | ACTIM |
| SUCROSE | C151H8M554 | IACT |
| METHYLCELLULOSE (15 MPA.S) | NPU9M2E6L8 | IACT |
| METHYLCELLULOSE (400 MPA.S) | O0GN6F9B2Y | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STRAWBERRY | 4J2TY8Y81V | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
Complete SPL Sections#
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
Cephalexin For Oral Suspension USP 125 mg/5mL and 250 mg/5mL
4 CONTRAINDICATIONS
Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
The following serious events are described in greater detail in the Warning and Precautions section: • Hypersensitivity reactions [see Warning and Precautions ( 5.1 )] • Clostridium difficile-associated diarrhea [see Warnings and Precautions ( 5.2 )] • Direct Coombs' Test Seroconversion [see Warnings and Precautions ( 5.3 )] • Seizure Potential [ see Warnings and Precautions ( 5.4 )] • Effect on Prothrombin Activity [see Warnings and Precautions (5.5)] • Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6)]
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
10 OVERDOSAGE
Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.
11 DESCRIPTION
Cephalexin oral suspension, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α- Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16 H 17 N 3 O 4 S•H 2 O and the molecular weight is 365.41. Cephalexin has the following structural formula: Inactive Ingredients : Colloidal silicon dioxide, FD&C Red # 40, methyl cellulose (15 premium LV), methyl cellulose (4AC premium), sodium benzoate, strawberry flavor, sucrose, xanthan gum.
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
16 HOW SUPPLIED/STORAGE AND HANDLING
Cephalexin Oral Suspension, USP250 mg/5 mL: NDC: 63629-8858-1: 200 For Suspensions in a BOTTLE Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Shake well before using. Keep tightly closed. *After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
17 PATIENT COUNSELING INFORMATION
Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin, other beta-lactams (including cephalosporins) or other allergens (5.1) Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider. Counsel patients that antibacterial drugs including cephalexin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin or other antibacterial drugs in the future. Manufactured by : Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: November, 2021 PT 2851-01
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cephalexin 250mg/5mL Susp #200 Extended Label