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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ANTIGRIP Cold & Cough Daytime

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:

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

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 7 days for pain and 3 days or 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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent of chronic cough as occurs with smoking, asthma, or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

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
  • nervousness, dizziness, or sleeplessness occur
  • a persistent cough or symptoms persist 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

AgeDose
adults and children 12 years of age and overone packet every 4 hours
children under 12 years of agedo not use

Other information

TAMPER EVIDENT: Do not use if carton or packets are torn or punctured.

Inactive ingredients

acesulfame potassium, aspartame, citric acid, flavor, isopropyl alcohol, maltodextrin, silicone dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions & comments?

PRINCIPAL DISPLAY PANEL

NDC 55758-314-18

ANTIGRIP® Daytime/Día

Cold & Cough/Gripe y Tos

Lemon/Limón

LABEL

ANTIGRIP DAYTIME 
acetaminophen, dextromethorphan hbr , phenylephrine hci powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-314
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-314-1818 in 1 CARTON03/28/2019
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/28/2019
Labeler - Pharmadel LLC (030129680)

Revised: 6/2020
Document Id: a745e8c6-85c1-7109-e053-2995a90a0fb4
Set id: 853012b8-d3b7-78d3-e053-2a91aa0ab0f2
Version: 3
Effective Time: 20200604
 
Pharmadel LLC