FDA Label for Antigrip Cough And Cold
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS & PURPOSES
- OTC - PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT ORBREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- DIST BY/ POR:
- PRINCIPAL DISPLAY PANEL
Antigrip Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients & Purposes
.
Otc - Purpose
Active ingredients (in each gel Softgel) | Purposes |
Acetaminophen 325 mg ............ | Pain reliever/ fever reducer |
Chlorpheniramine maleate 2 mg .......... | Antihistamine |
Dextromethorphan HBr 10 mg.......... | Cough suppressant |
Uses
Temporarily relieves common cough and cold symptoms due to
- minor aches and pain
- headache
- runny nose
- sneezing
- minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses in 24 hours, which is the maximum daily amount for this product
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product 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.
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 prescription monoamine oxidase inhibitors (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 The User
- is a child with pain from arthritis
- has liver disease
- has glaucoma
- has a breathing problem such as emphysema or chronic bronchitis
- has difficulty in urination due to enlargement of the prostate gland
- has a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- has a cough that is accompanied by excessive phlegm (mucus)
- is taking sedatives or tranquilizers
Ask A Doctor Or Pharmacist Before Use If The User
is taking the blood thinning drug warfarin
When Using This Product
- may cause marked drowsiness
- may cause excitability, especially in children
- may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages while taking this product
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- a cough comes back or occurs with a rash headache that lasts. These could be signs of a serious condition.
If Pregnant Orbreast-Feeding,
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
- take each dose with plenty of water
Age | Dose |
Adults and children 12 years and older | 2 softgels, every 6 hours not to exceed 4 doses in 24 hours |
children 6 to under 12 years of age | 1 softgel, every 4 hours not to exceed 5 doses in 24 hours |
children under 6 years of age | do not use |
Other Information
- store between 68-77°F (20-25"C)
- avoid excessive heat
Inactive Ingredients
D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water
Dist By/ Por:
PHARMADEL LLC
New Castle, DE 19720
Questions/ Preguntas? +1-866-359-3478
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