VANAPAIN PM- choline salicylate, diphenhydramine hydrochloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

GM Pharmaceuticals, Inc.

INN (International Name):

CHOLINE SALICYLATE

Composition:

CHOLINE SALICYLATE 870 mg in 57 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- For relief of occasional sleeplessness when associated with minor aches and pains. - Helps you fall asleep.

Authorization status:

OTC monograph not final

Summary of Product characteristics

VANAPAIN PM- CHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE LIQUID
GM PHARMACEUTICALS, 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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VANAPAIN
PM
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(PER 57 ML)_
Choline Salicylate (NSAID*) 870 mg
Diphenhydramine Hydrochloride 50 mg
*non-steroidal anti-inflammatory drug
_PURPOSE_
Pain reliever
Nighttime sleep-aid
US ES
For relief of occasional sleeplessness when associated with minor
aches and pains.
Helps you fall asleep.
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: Salicylates (NSAIDs) may cause a severe allergic
reaction which may include:
hives
skin reddening
rash
facial swelling
shock
asthma (wheezing)
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 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 time than directed
®
DO NOT USE
if you have ever had an allergic reaction to salicylates (including
aspirin) or any other pain
reliever/fever reducer
unless you have time for a full night's sleep
in children under 12 years of age
with any other product containing diphenhydramine, even one used on
skin
if you have sleeplessness without pain
ASK A DOCTOR BEFORE USE IF
stomach bleeding warning applies to you
you have a history of stomach problems such as heartburn, ups