FDA Label for Antigrip Daytime
View Indications, Usage & Precautions
- 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 DOCTOR IF
- IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS & COMMENTS?
- PRINCIPAL DISPLAY PANEL
Antigrip Daytime 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.
Otc - Purpose
Active ingredients (in each packet) | Purposes |
Acetaminophen 650 mg……………………………………………………………… | Pain reliever/ fever reducer |
Dextromethorphan HBr 20 mg…………………………………………………………… | Cough suppressant |
Phenylephrine HCI 10 mg…….………………………………..…………………………… | Nasal decongestant |
Uses
For the temporary relief of the common cough and cold/flu symptoms:
- reduces fever
- sore throat
- headache
- muscular aches
- backaches
- minor aches and pains
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies
- cough due to minor throat and bronchial irritation
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 packets 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
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
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 non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product
- to sedate a child
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- taking sedatives or tranquilizers
- a persistent or chronic cough as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
When Using This Product
- may cause drowsiness; alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask Doctor If
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- redness or swelling is present
- symptoms persists for more than 7 days, gets worse, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast 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
- DO NOT EXCEED RECOMMENDED DOSE
- take every 4 hours; do not exceed 6 packets in a 24 hour period
- dissolve the contents of one packet into 8 oz. of hot water and sip while hot; consume entire drink within 10-15 minutes
- if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.
Age | Dose |
adults and children 12 years of age and over | one packet every 4 hours |
children under 12 years of age | do not use; unless directed by a doctor |
children under 6 years of age | do not use |
Other Information
- each packet contains: sodium 26.73 mg, potassium 9.71 mg
- phenylketonurics: contains phenylalanine 14 mg per packet
- store at room temperature 68-77°F (20-25°C)
- avoid excessive heat and moisture
TAMPER EVIDENT: Do not use if carton or packets are torn or punctured.
Inactive Ingredients
acesulfame potassium, artificial flavor, aspartame, citric acid, colloidal silicon dioxide, isopropyl alcohol, maltodextrin, tribasic calcium phosphate, sodium citrate, sucrose, water
Questions & Comments?
1-866-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadel.com
Principal Display Panel
Oral Powder Solution/Solución oral de Polvo
NDC 55758-314-18
ANTIGRIP®
Daytime/Día
Cold & Cough/Gripe y Tos
Lemon/Limón
Relieves/Alivia
- Sore Throat Pain/Dolor de Garganta
- Body Ache/Dolor de Cuerpo
- Muscular Pains/Dolores Muscular
- Headache/Dolor de Cabeza
- Runny Nose/Secreción Nasal
- Sneezing/Estornudos
- Cough/Tos
- Fever/Fiebre
Acetaminophen/Acetaminofeno
Dextromethorphan HBr/Dextromethorphan HBr
Phenylephrine HCI/Fenilefrina HCL
18 Daytime Packets/Sobres de Día
per packet/por paquete 10g
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