Otc - Purpose
| Active ingredients (in each tablet) | Purposes |
| Acetaminophen 325 mg................... | Pain reliever/ fever reducer |
| Chlorpheniramine maleate 2 mg ........... | Antihistamine |
| Phenylephrine HCl 5 mg ..................... | Nasal decongestant |
Antigrip Tablet, Effervescent
FDA Label NDC 55758-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Antigrip (NDC 55758-500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the temporary relief of symptoms due to the common cold/ flu:
- runny nose
- sneezing
- nasal congestion
- minor aches and pain
- headache
- and temporarily reduces fever
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash. If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Sore throat warning: If sore throat is severe, persists for more than 2 days, and 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 you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- do not exceed the recommended dosage
- may cause drowsiness
- may cause excitability, especially in children
- avoid alcoholic beverages while taking this product
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- pain or nasal congestion persists for more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of an accidental 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.
Directions
■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor.
■ children under 12 years of age: do no use
Other Information
- each tablet contains: potassium 10mg, sodium 246mg
- store below 77°F (25°C) and a dry place
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, FD&C red #40, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, strawberry flavor, sucralose, water.
Questions Or Comments?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Dist. By:
Pharmadel LLC.
New Castle, DE 19720
* Please review the disclaimer below.
