ANTIGRIP NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl powder, for solution 
Pharmadel LLC

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Antigrip Nighttime Tea G-H-L (AS)

Drugs Facts

Active Ingredients & Purposes

Active ingredients (in each packet)Purposes
Acetaminophen 325 mg…………………………………Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………...Cough suppressant

Doxylamine succinate 6.25 mg .....................................

Antihistamine

Phenylephrine HCI 5 mg…….…………………………..

Nasal decongestant

Uses

Temporary relieves common cold/flu symptoms:

Warnings

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

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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you

  • have liver disease
  • have heart disease
  • have high blood pressure
  • have thyroid disease
  • have diabetes
  • have glaucoma
  • have a cough that is accompanied by excessive phlegm (mucus)
  • have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • have difficulty urinating due to an enlarged prostate gland
  • are taking sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • may cause excitability, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • may cause marked drowsiness

Stop use and ask doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • redness or swelling is present
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

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 (1) packet every 4 hours,

take every 4 hours; do not exceed 6 packets in a 24 hours

children under 12 years of agedo not use

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, isopropyl alcohol, lemon ginger honey flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions & 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

PRINCIPAL DISPLAY PANEL

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ANTIGRIP  NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-382
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon - Ginger - Honey) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-382-1818 in 1 CARTON03/28/2024
1NDC:55758-382-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/28/2024
Labeler - Pharmadel LLC (030129680)

Revised: 3/2024
Document Id: 14ac7b0a-30d9-e209-e063-6394a90a5c14
Set id: 12de30fd-95b6-f16d-e063-6294a90aeba2
Version: 4
Effective Time: 20240327
 
Pharmadel LLC