ACETAMINOPHEN CONGESTION AND PAIN- acetaminophen, phenylephrine hcl tablet, film coated 
Major Pharmaceuticals

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Major Pharmaceuticals Acetaminophen Congestion and Pain Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

•
temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
•
headache
•
sinus congestion and pressure
•
nasal congestion
•
minor aches and pains
•
helps decongest sinus openings and passages
•
promotes sinus drainage
•
helps clear nasal passages
•
temporarily reduces fever

Warnings

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

•
more than 4,000 mg of acetaminophen in 24 hours
•
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.
•
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
•
trouble urinating due to an enlarged prostate gland

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

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

•
do not take more than directed (see overdose warning)

adults and children 12 years and over
•
take 2 caplets every 4 hours
•
swallow whole – do not crush, chew or dissolve
•
do not take more than 10 caplets in 24 hours

children under 12 years

ask a doctor

Inactive ingredients

acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-616-2471

Principal Display Panel

Compare to the active ingredients in Tylenol® SINUS + HEADACHE

Acetaminophen

CONGESTION AND PAIN

CAPLETS

Acetaminophen – Pain reliever / Fever reducer

Phenylephrine HCl – Nasal decongestant

Relieves: Sinus Headache, Sinus Pressure & Nasal Congestion

Actual Size

For Adults

24 CAPLETS

with cool Blast Flavor

NON-DROWSY

DAYTIME

272-5c-acetaminophen.jpg
ACETAMINOPHEN CONGESTION AND PAIN 
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize16mm
FlavorVANILLA (menthol) Imprint Code L272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6760-2412 in 1 CARTON01/15/200709/30/2021
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/15/200709/30/2021
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2024
Document Id: b8212d92-1887-44bb-bb90-172b024b1574
Set id: 29bd1c43-fe8d-45d1-ac7b-b8d991f47f38
Version: 3
Effective Time: 20241024
 
Major Pharmaceuticals