OTC Medication Information: Pressure and Pain PE

PRESSURE AND PAIN PE- acetaminophen and phenylephrine hydrochloride tablet, coated
Chain Drug Marketing Association

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.

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Phenylephrine HCl 5 mg Nasal decongestant

Uses

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

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

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

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not take more than 10 caplets in 24 hours
children under 12 years
  • ask a doctor

Other information

  • store between 20-25ºC (68-77ºF) in a dry place
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6, hypromellose, lactose, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

PRINCIPAL DISPLAY PANEL

NDC 63868-971-24

QUALITY CHOICE

†Compare to Active Ingredients in SUDAFED PE® Pressure + Pain

Pressure + Pain PE

Pain Reliever / Fever Reducer, Nasal Decongestant

Acetaminophen, Phenylephrine HCl

For Relief of:

Sinus Headache

Sinus Pressure & Congestion

24 Caplets

SEE NEW WARNINGS INFORMATION & DIRECTIONS

24 count
(click image for full-size original)
PRESSURE AND PAIN PE
acetaminophen and phenylephrine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-971
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
LACTOSE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
STARCH, CORN
PROPYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color orange Score no score
Shape OVAL Size 17mm
Flavor Imprint Code AAA;1114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-971-24 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (63868-971-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/29/2007
Labeler — Chain Drug Marketing Association (011920774)

Revised: 10/2019 Chain Drug Marketing Association

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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