ANTIGRIP DAYTIME- acetaminophen, dextromethorphan hbr , phenylephrine hci powder, for solution

ANTIGRIP Daytime by

Drug Labeling and Warnings

ANTIGRIP Daytime by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Facts

Active Ingredients & Purposes

• 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

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 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

INGREDIENTS AND APPEARANCE

ANTIGRIP DAYTIME 
acetaminophen, dextromethorphan hbr , phenylephrine hci powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-314-18	18 in 1 CARTON	03/28/2019
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/28/2019

Labeler - Pharmadel LLC (030129680)