FREDS EFFERVESCENT ANTACID PAIN RELIEF- aspirin, citric acid, sodium bicarbonate tablet, effervescent

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
12-11-2020

Aktiv ingrediens:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Tilgjengelig fra:

Freds, Inc.

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

Aspirin 325 mg NSAID* . . . . . . . . . . . . . . . . . . . . . .Pain reliever Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . Antacid Sodium bicarbonate (heat-treated) 1916 mg . . . ... Antacid *Nonsteroidal anti-inflammatory drug ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains) ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product. ■ stomach bleeding warning applies to you ■ 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 ■ presently taking a prescription drug. Antacids may interact with certain prescription drugs. ■ taking a prescript

Autorisasjon status:

OTC monograph final

Preparatomtale

                                FREDS EFFERVESCENT ANTACID PAIN RELIEF- ASPIRIN, CITRIC ACID, SODIUM
BICARBONATE TABLET, EFFERVESCENT
FREDS, 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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FRED'S EFFERVESCENT ANTACID PAIN RELIEF
ACTIVE INGREDIENTS (IN EACH EFFERVESCENT TABLET)
Aspirin 325 mg NSAID*
Citric acid 1000 mg
Sodium bicarbonate (heat-treated) 1916 mg
*Nonsteroidal anti-inflammatory drug
PURPOS E
Aspirin 325 mg NSAID*. . . . . . . . . . . . . . . . . . . . . .Pain
reliever
Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . .
Antacid
Sodium bicarbonate (heat-treated) 1916 mg . . . ... Antacid
*Nonsteroidal anti-inflammatory drug
USES FOR THE TEMPORARY RELIEF OF
■ heartburn, acid indigestion and sour stomach when accompanied by
headache or body aches and pains
■ upset stomach with headache from overindulgence in food or drink
■ pain alone (headaches or body aches and pains)
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.
ALLERGY ALERT: Aspirin may cause a severe allergic reaction which may
include: ■ hives ■ facial
swelling ■ asthma (wheezing) ■ shock
STOMACH BLEEDING WARNING: This product contains a nonsteroidal
anti-inflammatory drug (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 this product
■ take more or for a longer t
                                
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