DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride solution 
Foundation Consumer Healthcare

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Dimetapp ®
Multi-Symptom Cold and Flu

Drug Facts

Active ingredients (in each 10 mL)Purposes
Acetaminophen, 320 mgPain reliever/fever reducer
Diphenhydramine HCl, 12.5 mgAntihistamine/cough suppressant

Uses

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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

  • to sedate a child or to make a child sleepy
  • in a child under 6 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if user has

  • liver disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if user is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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
  • cough comes back or occurs with fever, 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 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 and over20 mL every 4 hours
do not take more than 6 doses in any 24-hour period
children 6 to under 12 years10 mL every 4 hours
do not give more than 5 doses in any 24-hour period
children under 6 yearsdo not use

Other information

Inactive ingredients

anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

Distributed by:
Foundation Consumer Healthcare, LLC, Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NEW FORMULA

CHILDREN'S
Dimetapp ®

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHARMACIST
RECOMMENDED

Multi-
Symptom
Cold & Flu

Relieves + comforts:

6+
YRS

4 FL OZ
(118 mL)

Red Grape Flavor • Alcohol Free

Dimetapp 4oz Carton

DIMETAPP  MULTI-SYMPTOM COLD AND FLU
acetaminophen, diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-335
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN320 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-335-041 in 1 CARTON06/01/2024
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/01/2024
Labeler - Foundation Consumer Healthcare (079675882)

Revised: 6/2024
Document Id: 178fd0c9-665a-a6e0-e063-6394a90a0534
Set id: 178fe95b-e1ed-43b2-e063-6294a90a7a78
Version: 1
Effective Time: 20240601
 
Foundation Consumer Healthcare