Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Sinus Pressure And Pain (NDC 70000-0161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Nasal decongestant
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid
1-800-426-9391
LEADER™
NDC 70000-0161-1
Maximum Strength ι Adult
Sinus Pressure + Pain
Acetaminophen ι Pain Reliever / Fever Reducer
Phenylephrine HCl ι Nasal Decongestant
Non-Drowsy
Relieves:
Sinus Headache, Sinus Pressure,
Nasal Congestion
24 CAPLETS
Actual Size
COMPARE TO
SUDAFED PE® PRESSURE + PAIN
active ingredients*
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
REV. 10/17
*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN.
50844 REV0417A50208
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
CardinalHealth™
ALL LEADER™ Brand Products Have a
100% Money Back Guarantee
Return to place of purchase if not satisfied.
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the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.
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