INDICATIONS
The solution is a combination of Guaifenesin and Codeine
CODEINE PHOSPHATE
GUAIFENESIN
RELATUSSIN AC Ⓡ infections, which helps you to cough out through your mouth.
GUAIFENESIN
10mg/100mg per 5mL Syrup
Expectorant / Cough Suppressant
FORMULATIONS
Each 5 mL (1 teaspoonful) contains:
Guaifenesin...............................100 mg
Codeine Phosphate..................10 mg
Alcohol.......................................3.5 % v/v
PRODUCT DESCRIPTION
Relatussin AC Ⓡ syrup is a red-colored syrup, a cherry-
flavored syrup.
PHARMACODYNAMICS
This syrup preparation combines the expectorant, guaifenesin,
with the cough suppressant, codeine. Guaifenesin enhances the
output of lower respiratory tract fluid. The enhanced flow of less
viscid secretions promotes and facilitates the removal of mucus.
Codeine is a centrally acting agent which elevates the threshold
for cough. As a result, dry, unproductive coughs become more
productive and less frequent.
PHARMACOKINETICS
Guaifenesin
Guaifenesin is administered orally. The plasma half-life is
approximately 1 hour. Guiafenesin is rapidly hydrolyzed (60%
within seven hours) and then excreted in the urine, with beta-
(2-methoxyphenoxy)-lactic acid as its major urinary metabolite.
No unchanged drug was detected in the urine following
administration. Renal stones that developed during drug
therapy have been documented to contain beta-(2-
methoxyphenoxy)-lactic acid and other guaifenesin metabolites.
Other pharmacokinetic parameters of guaifenesin are not
known.
Codeine Phosphate
Absorption: Well absorbed after oral or parenteral
administration. It’s about two-thirds as potent orally as
parenterally.
Distribution: Distributed widely throughout the body; it crosses
the placental barrier and enters breast milk.
Metabolism: Metabolized mainly in the liver, by demethylation
or by conjugation with glucuronic acid.
Excretion: Excreted mainly in the urine as norcodeine and free
and conjugated morphine.
phosphate liquid, which is a cough suppressant or expectorant.
This medicine helps relieve cough due to minor throat and
bronchial irritations that may occur with the common cold or
inhaled irritants. Guaifenesin is an expectorant that helps reduce
chest congestion caused by the common colds, allergies, or
Meanwhile, Codeine is both an opiate analgesic and antitussives,
which are used to relieve mild to moderate pain. It can be used
in reducing cough when combined with other medications.
DOSAGE AND MODE OF ADMINISTRATION
This is taken orally every 4 hours. Administer with a full glass of
water. May be taken with food or milk to minimize GI irritation.
AGE DOSE
Adults and children 12 10 mL (2 teaspoonfuls)
years and over
Children 6 to 12 years old 5 mL (1 teaspoon)
Children under 6 years old Consult a doctor
CONTRAINDICATIONS
This medication is contraindicated in patients with a history of
hypersensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS
It should not be used in adults and children, who are suffering
from chronic pulmonary disease or shortness of breath or
children who are taking other drugs unless it is prescribed by a
doctor. It should not be taken when your cough lasts more than
7 days, comes back, or occurs with fever, rash, or headache that
is persistent because these can be symptoms of a serious
condition. Medication is discontinued when you start to have
aggravated constipation.
PREGNANCY AND LACTATION
Breast-feeding is not recommended when taking codeine;
guaifenesin products due to the risk of serious adverse reactions
including excessive sedation and respiratory depression in the
breast-fed infant. If an infant is exposed to codeine through
breast milk, they should be monitored for excessive sedation
and respiratory depression. Withdrawal symptoms can occur in
breast-fed infants when maternal use of an opioid is stopped or
when breast-feeding is stopped.
ASK A DOCTOR IF YOU HAVE
• A cough with too much phlegm (mucus)
• A persistent or chronic cough as occurs
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives, tranquilizers and drugs for depression,
especially monoamine oxidase inhibitors (MAOIs). These
combinations may cause greater sedation (drowsiness) than is
caused by the product used alone.
 WHEN SHOULD YOU CONSULT YOUR DOCTOR?
If any undesirable effect occurs
INTERACTIONS
Caution should be used when taking this product with sedatives,
tranquilizers and drugs used for depression, especially
monoamine oxidase inhibitors (MAOIs). These combinations
may cause greater sedation (drowsiness) than is caused by the
product used alone.
poisoning, always lock safety caps and immediately place the
medication in a safe location – one that is up and away and out
of their sight and reach.
CAUTIONS
Food, Drugs, Devices, and Cosmetics Act prohibits dispensing
without prescription.
Keep all medicines out of children.

ADVERSE DRUG REACTIONS ADR REPORTING STATEMENT

These effects may occur: drowsiness, dizziness, For suspected adverse drug reaction, seek medical attention
lightheadedness, facial flushing, nausea, vomiting, or immediately and report to the FDA at www.fda.gov.ph and
constipation. If they worsen or persist, consult your doctor Unison Pharmaceuticals, Inc. at 811-5721 or
promptly. Tell your doctor right away if you have any serious side unison_pharmaceuticals@gmail.com. By reporting undesirable
effects, including interrupted breathing during sleep (sleep effects, you can help provide more information on the safety of
apnea), mental/mood changes (e.g., hallucinations), this medicine.
fast/irregular heartbeat, trouble urinating. Get medical help
right away if you have any very serious side effects, including FDA REGISTRATION NUMBER: DQ-CA91012
seizure.
DATE OF FIRST AUTHORIZATION: January 2018
WHAT SHOULD YOU DO IF YOU MISSED A DOSE? DATE OF RENEWAL OF AUTHORIZATION: January 2020
Take the missed dose as soon as you remember. Skip the missed
dose if it is almost time for your next scheduled dose. Do not use DATE OF REVISION OF PACKAGE INSERT: January 2020
extra medicine to make up the missed dose.
LOT NUMBER: MNF202H
OVERDOSE AND TREATMENT DATE MAUFACTURED: August 2020
Guaifenesin and Codeine Phosphate overdose can be fatal,
especially in a child or other person using the medicine without EXPIRY DATE: August 2022
a prescription. Overdose symptoms may include slow breathing
and heart rate, severe drowsiness, muscle weakness, cold and MARKETING AUTHORIZATION HOLDER AND MANUFACTURER:
clammy skin, pinpoint pupils, and fainting

If someone has taken more than the recommended dosage, UNISON PHARMACEUTICALS,
consult a doctor. If someone has overdosed and has serious LABORATORIES INC.
1621 Piy Margal Street,
symptoms such as passing out or trouble breathing, call 911.
Sampaloc, Manila
Otherwise, call a poison control center right away.

STORAGE CONDITIONS
• Store at room temperature 15oC - 30oC (59oF - 86oF)
• Keep out of reach of children.
• Protect from light.
• Always keep container tightly closed
• Do not freeze

AVAILABILITY
Syrup: Available in bottle of 60 mL, 120mL and 500 mL

INSTRUCTIONS FOR HANDLING AND DISPOSAL

Unneeded medications should be disposed of in special ways to
ensure that pets, children, and other people cannot consume
them. However, you should not flush this medication down the
toilet. Instead, the best way to dispose of your medication is
through a medicine take-back program. Talk to your pharmacist
or contact your local garbage/recycling department to learn
about take-back programs in your community.

It is important to keep all medication out of sight and reach of

children as many containers are not child-resistant and young
children can open them easily. To protect young children from