FDA records indicate that there are no current recalls for this drug.
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Childrens Pain Relief Grape Flavor Recall
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Questions & Answers
Side Effects & Adverse Reactions
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
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.
- 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
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
- 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
liver disease.
Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.
Stop use and ask a doctor if- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporaily relieves minor aches and pains due to:
- the common cold
- headache
- flu
- sorethroat
- toothache
- temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Childrens Pain Relief Grape Flavor Manufacturers
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Value Merchandisers Company, Inc.
Childrens Pain Relief Grape Flavor | Viiv Healthcare Company
2.1 Screening for HLA-B*5701 Allele prior to Starting TRIUMEQScreen for the HLA‑B*5701 allele prior to initiating therapy with TRIUMEQ [see Boxed Warning, Warnings and Precautions (5.1)].
2.2 Recommended DosageTRIUMEQ is a fixed-dose combination product containing 600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine. The recommended dosage regimen of TRIUMEQ in adults is one tablet once daily orally with or without food.
2.3 Dosage Recommendation with Certain Concomitant MedicationsThe dolutegravir dose (50 mg) in TRIUMEQ is insufficient when coadministered with medications listed in Table 1 that may decrease dolutegravir concentrations; the following dolutegravir dosage regimen is recommended.
Table 1. Dosing Recommendations for TRIUMEQ with Coadministered Medications
Coadministered Drug
Dosing Recommendation
Efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, or rifampin
The recommended dolutegravir dosage regimen is 50 mg twice daily. An additional dolutegravir 50-mg tablet, separated by 12 hours from TRIUMEQ, should be taken.
2.4 Not Recommended Due to Lack of Dosage AdjustmentBecause TRIUMEQ is a fixed-dose tablet and cannot be dose adjusted, TRIUMEQ is not recommended in:
• patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations (8.6)]. • patients with mild hepatic impairment. TRIUMEQ is contraindicated in patients with moderate or severe hepatic impairment [see Contraindications (4), Use in Specific Populations (8.7)].
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