ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated 
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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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TCR - 1125 - 2019-1007

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever
Diphenhydramine HCl 12.5 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

Liver warning

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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • 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.

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.
  • with any other product containing diphenhydramine, even one used on skin
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not take more than 12 caplets in 24 hours
children under 12 years
  • ask a doctor

Other information

Inactive ingredients

colloidal silicon dioxide, color black, copovidone, croscarmellose sodium, D&C yellow #10, FD&C blue #1, hypromellose, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

PRINCIPAL DISPLAY PANEL

NDC 36800-501-02

TopCare health

Allergy Plus Sinus Headache

ACETAMINOPHEN - PAIN RELIEVER

DIPHENHYDRAMINE HCL - ANTIHISTAMINE

PHENYLEPHRINE HCL - NASAL DECONGESTANT

RELIEF OF:

Sinus Headache

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

Sinus Congestion

Sinus Pressure

OUR PHARMACISTS RECOMMEND

24 CAPLETS

actual size

image description

ALLERGY PLUS SINUS HEADACHE 
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize17mm
FlavorImprint Code AAA;115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-501-022 in 1 CARTON07/01/2013
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2013
Labeler - TopCare (006935977)

Revised: 10/2019
Document Id: 94573dee-b430-37da-e053-2995a90aab8d
Set id: 7766bb8b-10a6-4dd2-8e09-f72ebbf948ef
Version: 2
Effective Time: 20191007
 
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