PAIN AND SINUS RELIEVER- acetaminophen and phenylephrine tablet

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]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

PURPOSE

pain reliever/fever reducer

decongestant

INDICATIONS & USAGE

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 freer breathing

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

WARNINGS

Warnings:

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

Alergy 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 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.

Ask a doctor or pharmacist before use if:  you are taking the blood thinning drug warfarin.

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  liver 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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 as directed by a doctor.

Children under 12 years: Consult a doctor.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN AND SINUS RELIEVER 
acetaminophen and phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-194
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (LIGHT BLUE)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR33
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-194-68	100 in 1 CARTON	04/09/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67060-194-67	250 in 1 CARTON	04/09/2015
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/09/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-194)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-194)