BLUE SKY BREAKOUT

[~ Blue ~]

$SHMN(.0007)~ SohMed Pain Reliever Medically reviewed by Drugs.com. Last updated on Aug 12, 2020.

Dosage form: tablet
Ingredients: Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg
Labeler: SOHM Inc.
NDC Code: 50405-008

Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

SohMed™ Pain Reliever


Drug Facts

Active ingredients (in each caplet) Purposes
This Product is not manufactured or distributed by Novartis Consumer Healthcare, Inc. Owner of registered trademark Excedrin®.
Acetaminophen 250mg pain reliever
Aspirin 250mg (NSAID) Pain reliever
Caffeine 65mg pain reliever aid
Uses
Temporarily relieves minor aches and pains due to:
Headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual & menstrual cramps.
Warnings
Reye's syndrome
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention.

Allergy alert
aspirin may cause a severe allergic reaction which may include :

hives
facial swelling
asthma (wheezing)
shock
Liver warning

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

adult takes more than 8 caplets in 24 hours, which is the maximum daily amount.
Child takes more than 5 caplets in 24 hours.
with other drugs containing acetaminophen.
3 or more alcoholic drinks every day while using this product.
Stomach bleeding warning
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using product.
take more or for a longer time than directed.
Caffeine warning
The recommended dose of this product contains about as much as caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use
if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
with any drug containing acetaminophen (prescription or nonprescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
you have a liver disease
stomach bleeding warning applies to you
you have not been drinking fluids
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma
you have lost a lot of fluids due to vomiting or diarrhea
Ask a doctor or pharmacist before use if you are taking

any other drug containing an NSAID (prescription or nonprescription)
a blood thinning (anticoagulant) or steroid drug
a prescription drug for diabetes, gout or arthritis
any other drug, or are under a doctor's care for any serious condition
Stop use and ask a doctor if
an allergic reaction occurs. seek medical help right away
you experience any of the following signs of stomach bleeding
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
ringing in the ears or loss of hearing occurs
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days

any new symptoms appear if pregnant or breast-feeding, ask health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.

Overdose Warning
In case of overdose, get medical help or contact a poison control center right away. 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 use more than directed
drink a full glass of water with each dose
adults and children 12 years and over : take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
children under 12 years: asks a doctor.
Other information
store at controlled room temperature 20°-25°C(68°-77°F)
See end flap or expiration date and lot number.
Inactive ingredients
benzoic acid, carnauba wax, FD&C blue#1, hydroxypropylcellulose, Hypromellose,light mineral oil, microcrystalline cellulose, polysorbate 20, Povidone, propylene glycol,simethicone emulsion, Sorbitan monolaurate, stearic acid, titanium dioxide.

Question and comment?
1(856) 2863646

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C, Buena Park, CA 90621

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton
SohMed™

NDC XXXXXXXXXX

*Compare to the active ingredients in Excedrin®

Extra Strength
Pain Reliever

Acetaminophen 250 mg,
Aspirin 250 mg (NSAID) Caffeine 65 mg

Relieves minor aches and pains

24 Caplets


SOHMED PAIN RELIEVER
acetaminophen, aspirin, and caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50405-008
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 250 mg
Aspirin (Aspirin) Aspirin 250 mg
Caffeine (Caffeine) Caffeine 65 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
BENZOIC ACID
HYDROXYPROPYL CELLULOSE (TYPE H)
FD&C BLUE NO. 1
HYPROMELLOSES
LIGHT MINERAL OIL
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 20
POVIDONES
PROPYLENE GLYCOL
DIMETHICONE
SORBITAN MONOLAURATE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code CRX
Contains
Packaging
# Item Code Package Description
1 NDC:50405-008-24 1 BOTTLE, PLASTIC in 1 CARTON
1 24 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 08/25/2013

Labeler - SOHM Inc. (009303848)
Document Id: 53f2e6c3-b328-4867-a442-3bc74cfaf799
Set id: 3ba45f29-d6b9-4bda-a830-9999791013cb
Version: 1
Effective Time: 20130822

SOHM Inc.
Medical Disclaimer

https://www.drugs.com/otc/126788/sohmed-pain-reliever.html