PAIN AND SINUS RELIEVER by ADVANCED FIRST AID, INC. / ULTRA SEAL CORPORATION / ULTRA TAB LABORATORIES, INC.

PAIN AND SINUS RELIEVER by

Drug Labeling and Warnings

PAIN AND SINUS RELIEVER by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN AND SINUS RELIEVER- acetaminophen and phenylephrine tablet 
ADVANCED FIRST AID, INC.

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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ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

pain reliever/fever reducer

decongestant

Uses: temporarily: relieves nasal congestion associated with sinusitis relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies relieves sinus congestion and pressure, helps decongest sinus openings and passages restores free breathing

temporarily relieves minor aches, pains, and fever associated with: headache common cold toothache backache muscular aches menstrual cramps

Warnings:

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: you take more than 8 tablets in 24 hours you take with other drugs containing acetaminophen (prescription or non-prescription) you have 3 or more alcoholic drinks every day while using this product

Do not use:

with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. more than the recommended dose for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this prouct.

Stop use and ask a doctor if:

symptoms do not improve pain or fever persists or gets worse new symptoms occur redness or swelling is present nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you have:

heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland

When using this product do not exceed recommended dose.

If pregnant or breast-feeding baby, 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:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets

in 24 hours, or asdirected by a doctor.

Children under 12 years: Consult a doctor.

Inactive Ingredients: FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, and stearic acid.

PAIN AND SINUS RELIEVER

PAIN AND SINUS RELIEVER 
acetaminophen and phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67060-140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) acetaminophen500 
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorblue (LIGHT BLUE) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67060-140-68100 in 1 CARTON04/09/201511/20/2019
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 67060-140-67250 in 1 CARTON04/09/201511/20/2019
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/09/201511/20/2019
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-140)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-140)

Revised: 11/2019
 
ADVANCED FIRST AID, INC.