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NDC 69676-0058-07 Genexa Childrens Acetaminophen 80 mg/1 Details
Genexa Childrens Acetaminophen 80 mg/1
Genexa Childrens Acetaminophen is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 69676-0058-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 69676-0058 |
|---|---|
| Product ID | 69676-0058_e779cfbf-ee36-35cc-e053-2995a90a3815 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Genexa Childrens Acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Genexa Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69676-0058-07 (69676005807)
| NDC Package Code | 69676-0058-7 |
|---|---|
| Billing NDC | 69676005807 |
| Package | 1 BOTTLE in 1 CARTON (69676-0058-7) / 24 TABLET, CHEWABLE in 1 BOTTLE |
| Marketing Start Date | 2022-02-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d89fd9d8-d88e-3968-e053-2a95a90afc5f Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
SPL UNCLASSIFIED SECTION
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see Overdose warning)
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew tablets completely before swallowing; do not swallow tablets whole
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
| Weight | Age | Dose † |
| Under 24 lbs. | Under 2 years | Ask a doctor |
| 24-35 lbs. | 2-3 years | 2 tablets |
| 36-47 lbs. | 4-5 years | 3 tablets |
| 48-59 lbs. | 6-8 years | 4 tablets |
| 60-71 lbs. | 9-10 years | 5 tablets |
| 72-95 lbs. | 11 years | 6 tablets |
†or as directed by a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Inactive ingredients
acacia gum‡, calcium carbonate‡, organic carnauba wax, cellulose‡, citric acid‡, dextrose‡, dibehenin (vegetable source)‡, flavor‡, glycerin‡, grape flavor‡, organic guar gum, maltodextrin‡, organic palm olein, organic stevia rebaudiana leaf extract, organic
sunflower lecithin, xylitol‡
‡ natural
SPL UNCLASSIFIED SECTION
Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.
*This product is not manufactured or distributed by Johnson & Johnson Inc., owner of the registered trademark Children's Tylenol® Chewables Grape.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30318 | genexa.com
Made in the USA with globally sourced ingredients
R-20211230
NDC 69676-0058-7
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| GENEXA CHILDRENS ACETAMINOPHEN
acetaminophen tablet, chewable |
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| Labeler - Genexa Inc. (079751024) |